Product code OMP— General, Plastic Surgery
PICO Single Use Negative Pressure Wound Therapy System
- Classification name
- Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 215
- First cleared
- Most recent
FDA classification definition
“For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.”
Market context for product code OMP
FDA has cleared devices under product code OMP between 1997 and 2026, filed by 69 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code OMP
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OMP
1–100 of 215- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K253263 — ConvaVAC Negative Pressure Wound Therapy System
- K253199 — CURASYS 2 (EMDN0003)
- K260646 — RENASYS EDGE (66803126)
- K261291 — Nisus NPWT Canister 500-mL (CPC-500)
- K254019 — Wound Geni NPWT System
- K253429 — Genadyne ASTRA NPWT
- K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
- K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System
- K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
- K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
- K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port +1 more
- K233614 — Genadyne DUO NPWT
- K241061 — VERSA Negative Pressure Wound Therapy System (VCMPP-100)
- K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand)
- K241515 — NEXA NPWT System
- K231939 — Renasys Edge
- K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
- K230233 — Prospera Spectruum Negative Pressure Wound Therapy System
- K231646 — Carilex VT¿200-i NX
- K232379 — PREVENT Kit
- K230677 — Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
- K223388 — Invia® Integrated Dressing
- K221888 — Genadyne Hybrid Foam Dressings
- K221585 — 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
- K222859 — 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)
- K213906 — extriCARE 1000 Negative Pressure Wound Therapy System
- K213853 — RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large
- K221223 — extriCARE® 3000 Negative Wound Pressure Therapy System
- K221891 — UNO Negative Pressure Wound Therapy System
- K223041 — Renasys Edge (66803126)
- K212359 — PWD Negative Pressure Wound Therapy System
- K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) System
- K220560 — Dermatac Drape
- K220660 — Prevena Restor Adapti-Form Dressing
- K210107 — Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
- K211571 — Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
- K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
- K211318 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
- K202898 — Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
- K211521 — 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
- K211277 — Theia NPWT Foam Wound Dressing Kit
- K202823 — Innomed NPWT Silicone Foam Dressing
- K203316 — V.A.C.ULTA Negative Pressure Wound Therapy System
- K212320 — Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac
- K203693 — Nisus Touch Negative Pressure Wound Therapy Pump
- K203369 — Avance Solo Negative Pressure Wound Therapy (NPWT) System
- K202217 — Kendall NPWT Incision Management Device
- K202157 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
- K200223 — PocketDoc Micro Wound Therapy System
- K191101 — Kendall NPWT Incision Management Dressing Kit
- K201571 — ACTIV.A.C. Negative Pressure Wound Therapy System
- K200390 — V.A.C. DERMATAC Drape
- K190028 — UNO 30
- K191760 — PICO 14 Single Use Negative Pressure Wound Therapy System
- K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
- K190119 — Foryou NPWT Dressing Kit
- K182722 — XLR8 Abdominal Wound Dressing Kit
- K191460 — PWD Platform Wound Dressing 3 x 5 Oblong
- K182458 — Longterm NPWT Foam Dressing Kit
- K181505 — V.A.C. DERMATAC Drape
- K181929 — MiMo(TM) Negative Pressure Wound Therapy System
- K181822 — RENASYS Touch; RENASYS Y-Connector
- K183543 — ACTIV.A.C. Therapy Unit
- K181507 — PREVENA RESTOR(TM) Incision Management System
- K182191 — Invia Abdominal Dressing Kit
- K182323 — PICO 7Y Single Use Negative Pressure Wound Therapy System
- K182409 — Applied Tissue Technologies PWD Platform Wound Dressing
- K181204 — RENASYS Y-Connector; RENASYS TOUCH
- K180840 — UNO Negative Pressure Wound Therapy System
- K180415 — Invia White Foam NPWT
- K180205 — AVELLE Negative Pressure Wound Therapy System
- K180698 — PICO 7 Single Use Negative Pressure Wound Therapy System
- K173407 — VT - 100, VT - 200
- K172725 — VT Dressing Kits
- K180855 — Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
- K172145 — Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
- K180618 — PICO Single Use Negative Pressure Wound Therapy System
- K180614 — PICO Single Use Negative Pressure Wound Therapy System
- K173426 — PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
- K173447 — V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
- K172005 — PICO 7 Single Use Negative Pressure Wound Therapy System
- K171499 — Occlusion Detection Dressing Kit
- K172521 — PICO Single Use Negative Pressure Wound Therapy System
- K172519 — PICO Single Use Negative Pressure Wound Therapy System
- K162610 — NEXA Negative Pressure Wound Therapy System
- K162159 — VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
- K163387 — PICO Single Use Negative Pressure Wound Therapy System
- K161599 — UNO Negative Pressure Wound Therapy System
- K170088 — Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
- K161432 — MyNeWT Negative Pressure Wound Therapy System
- K162790 — V.A.C.ULTA Negative Pressure Wound Therapy System
- K161418 — Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
- K160487 — V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
- K150960 — WoundPro Negative Pressure Wound Therapy System
- K161128 — Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
- K161935 — Avance Foam Dressing Kit - XL
- K161948 — Avance Gauze Dressing Kits
- K161797 — Avance Tubing, Avance Y-Connector, Avance ViewPad
- K161410 — VT·One, VT·One 60days
Data sourced from openFDA. This site is unofficial and independent of the FDA.