Product code FMI— General Hospital
Sterile Hypodermic Needles for Single Use
- Classification name
- Needle, Hypodermic, Single Lumen
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Total cleared
- 695
- First cleared
- Most recent
Market context for product code FMI
FDA has cleared devices under product code FMI between 1976 and 2026, filed by 387 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 FMI
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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 FMI
1–100 of 695- K261719 — Promisemed X-Safety Pen Needle
- K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
- K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
- K261829 — Profoject Dual-Safety Pen Needles
- K260739 — Profoject Pen Needles (Model A; Model B)
- K260855 — Profoject Safety Pen Needles
- K254273 — Verisafe Safety Sterile Needles (SSN)
- K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
- K253047 — PRESSONE
- K253622 — Safety Pen Needle
- K252886 — Pen Needle
- K250700 — Pen Injector Needle 32.5
- K252631 — Profoject Disposable Needle
- K250724 — Intraosseous Infusion Needles
- K250284 — TSK SELECT Needle
- K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
- K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
- K240355 — FROG (Filter Removal of Glass)
- K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
- K250658 — SureFine Pen Needle
- K243806 — Safety Winged Blood Collection Sets
- K242741 — ACE Cannula
- K242632 — Verifine® Pen Needles
- K240915 — ZIEN IO Intraosseous Access System
- K232165 — Sterile Safety Hypodermic Needles for Single Use +2 more
- K233037 — Sterile Hypodermic Needles for Single Use
- K233343 — SteriCap Safety Needle; VitreJect Safety Needle
- K230070 — MESORAM® Hypodermic Needle (13+ models)
- K230043 — Insulin Pen Needle
- K230959 — VitreJect® Needle; OcuSafe® Needle
- K231720 — Sterile Hypodermic Needles for Single Use
- K231723 — Sterile Safety Hypodermic Needles for Single Use
- K231729 — Sterile syringes for single use with/without needle
- K231255 — NovoFine® Plus
- K231261 — Altaviz Needle Kit II
- K231924 — EZ-IO Intraosseous Vascular Access System
- K230635 — Pen Needle
- K222852 — Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
- K222739 — Disposable Insulin Pen Needle
- K222417 — Shina Safety Needle
- K223327 — Sterile Aesthetic Cannula and Hypodermic Needle
- K222271 — Verisafe Safety sterile needles
- K203792 — Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
- K223286 — BD AutoShield Duo Pen Needle
- K223334 — Sterile Hypodermic Needles for Single Use
- K214004 — CCBIO ASCPO Needle
- K222681 — Altaviz Needle Kit
- K223353 — DropSafeTM SicuraTM
- K221178 — Disposable Insulin Pen Needle
- K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
- K220890 — IO Needle Safety Sheath
- K213183 — Safety Insulin Pen Needles
- K221066 — Sterile Hypodermic Needles for Single Use
- K221080 — Sterile Safety Hypodermic Needles for Single Use
- K220129 — Promisemed X-Safety Pen Needle
- K220603 — Disposable Medical Safety Hypodermic Needle
- K212095 — SurGuard3 Safety Hypodermic Needle
- K221176 — Insulin Pen Needle
- K213478 — BD Pen Needle
- K220614 — MEDOJECT fine Pen Needles
- K210748 — Well-life TM Pen Needles, Well-life TM Safety Pen Needles
- K213535 — Sterile Safety Hypodermic Needles for Single Use
- K212514 — Safety Pen Needle for Single Use, Insulin Pen Needles
- K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
- K210864 — Safety Pen Needle
- K211716 — DropSafe Safety Pen Needles
- K213407 — UltiCare Disposable Pen Needles
- K200932 — Blood Collection Needles
- K213156 — BD Nano 2nd Gen Pen Needle
- K212015 — BD Nano 2nd Gen Pen Needle
- K202319 — Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
- K211214 — Sterile Hypodermic Needles for Single Use
- K212805 — SteriCap Mini Needle and Standard Needles
- K210232 — Sterile Hypodermic Needles for Single Use
- K210399 — Unifine SafeControl
- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K211395 — NIO-I
- K211968 — NIO+ Adult
- K210059 — Promisemed Insulin Pen Needle
- K211293 — Safety Winged Blood Collection Sets
- K210258 — NovoFine
- K210065 — Verifine Safety Type Insulin Pen Needle
- K202492 — EZ-IO Intraosseous Vascular Access System
- K193422 — Easydrip Pen Needle, Easydrip Plus Pen Needle
- K202681 — Promisemed Covered Safety Pen Needle
- K202005 — NovoFine Plus 32G Tip x 4 mm
- K202682 — Promisemed Triple Safety Pen Needle
- K200017 — Eclipse DermaFlex Cannula
- K202340 — Droplet Pen Needle 30G & 33G
- K192464 — Injection Pen Needle
- K191644 — TK Safety Needle
- K192222 — EZ-Inject Single use Needle
- K192082 — Droplet Pen Needle 34G
- K192677 — Safety Insulin Pen Needle
- K190962 — Bella-mu
- K191643 — TK Sterile Hypodermic Needle
- K191488 — SAM IO Intraosseous Access System
- K191976 — Piper GO-IO Intraosseous Infusion System
- K191258 — Intraosseous infusion device
- K192057 — K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall
Data sourced from openFDA. This site is unofficial and independent of the FDA.