Product code FPA— General Hospital
INTRAVASCULAR ADMINISTRATION SET
- Classification name
- Set, Administration, Intravascular
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Total cleared
- 1,177
- First cleared
- Most recent
Market context for product code FPA
FDA has cleared devices under product code FPA between 1976 and 2026, filed by 476 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 FPA
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 FPA
1–100 of 1,177- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
- K250325 — BD Alaris Pump Infusion Set
- K251814 — EZ IV Administration Set
- K251854 — SteadiSet infusion set
- K243841 — Sparta Infusion Set for Insulin
- K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets
- K250616 — Clave Neutral-Displacement Needlefree Connectors
- K242692 — SteadiSet Infusion Set
- K242763 — JetCan® Pro Safety Huber Needle
- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
- K241058 — Lyka® PORT Needle Free Access Device (4170Y)
- K234129 — Ecomed Disposable Administration Sets
- K242126 — I.V. Administration Set
- K232475 — Disposable infusion set with needle
- K222766 — Disposable Extension Set
- K232328 — Insignis Syringe Infusion System
- K231707 — ResQ Administration Set
- K230528 — Extension Set
- K222780 — LILY Extension Tube and Needleless Connector
- K230343 — ProSeal Closed System Administration Set
- K221327 — BD Alaris Pump Infusion Sets
- K221411 — Surflo Winged Infusion Set
- K221121 — Volumat Polyethylene I.V. Administration Set
- K230992 — DJF Intravascular Administration Set
- K220301 — Volumat Line
- K223645 — I.V. Administration Set, I.V. Extension Set
- K223101 — BD Secondary Infusion Set
- K220288 — NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
- K220312 — Polyfusion IV Administration Sets
- K223088 — BD SmartSite Needle-Free Connector
- K222889 — FlowArt® Needle-Free Split Septum Valve
- K221069 — Infusion Sets for Single Use with Needles
- K221075 — Infusion Sets for Single Use
- K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
- K221518 — NP Medical nCompass Extension Set with Stabilizing Base
- K220267 — AMSafe NeuFlo Needleless Connector
- K212262 — PCA Syringe Sets
- K221473 — Flowart
- K221481 — NeutrArt
- K213846 — Q2 Blood Administration Sets
- K213588 — Q2 IV Administration Sets
- K213004 — Needle Free Connector
- K202437 — Infusion Sets for Single Use
- K213778 — IV Administration Set
- K212842 — Microvolume Luer Access Device
- K213089 — Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
- K203609 — Intravascular Administration Sets
- K202618 — IV Administration Sets
- K210381 — I.V. Administration Set
- K202279 — Insignis Subcutaneous Needle Sets
- K203796 — Firefly Needleless Connector
- K210544 — Medtronic Extended infusion set
- K210430 — Intravascular Extension Set
- K210217 — Needleless Connector
- K201626 — Safety Subcutaneous Infusion Set
- K200439 — Velano ExT Extension Set
- K202672 — Precision Delivery Infusion Set
- K201872 — NeutrArt
- K200425 — Female Luer Lock Cap
- K193088 — MaxZero Extension Sets with Needle-Free Connector(s)
- K200661 — Steripath Micro Blood Collection System
- K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets
- K191640 — TK Intravascular Administration Set
- K192681 — Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
- K192366 — Intravascular Extension Sets and Accessories
- K191362 — LifeFlow Blood System
- K191658 — IV Sets not made with PVC
- K190806 — Flowart
- K192647 — neria guard Infusion Set
- K180739 — Clearlink System Solution Set
- K190233 — K-Shield Advantage Port Access Infusion Set (PAIS)
- K180843 — HIgH-Flo Super26 Subcutaneous Needle Sets
- K182897 — Velano Vascular Q2 Extension Set
- K181870 — Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
- K182545 — Tamper Evident Cap with Male Luer Lock
- K181718 — BD FlowSmart Set/MiniMed Pro-Set
- K173665 — AMSafe Sure-Lok Needle-Free Connector
- K173361 — IV Administration Set
- K173879 — MiniMed Mio Advance infusion set
- K170595 — IV Administration Sets
- K162812 — Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
- K172544 — IV Fat Emulsion Administration Sets
- K170002 — Medline Blood Collection Set
- K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000)
- K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
- K171132 — Carefusion NeutraClear Needle-free connector
- K162951 — TUBETECH IV Administration Set
- K171957 — MaxZero Extension Sets with Needless Connector
- K161808 — Solution Set with 1.2 Micron Air Eliminating Filter
- K162826 — Encore Neutral
- K171101 — Closed Male Luer
- K162601 — Infusion Set for Single Use
- K163160 — Sterile Single-use Infusion Set
- K161898 — Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
- K162804 — Q2 Low Pressure Power Injection Extension Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.