FDA Product Code FMI: Needle, Hypodermic, Single Lumen
FDA product code FMI covers single-lumen hypodermic needles.
These devices consist of a hollow metallic cannula with a sharpened beveled tip designed to pierce skin and tissue for the injection of medications, aspiration of fluids, or delivery of vaccines. They are among the most widely used medical devices globally, available in a wide range of gauges and lengths.
FMI devices are Class II medical devices, regulated under 21 CFR 880.5570 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Terumo Europe N.V. and Promisemed Hangzhou Meditech Co., Ltd..
695
Total
695
Cleared
136d
Avg days
1976
Since
Declining activity -
23 submissions in the last 2 years
vs 32 in the prior period
Consistent review times:
128d avg (recent)
FDA 510(k) Cleared Needle, Hypodermic, Single Lumen Devices (Product Code FMI)
695 devices
Cleared
Aug 25, 2026
Promisemed X-Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital
91d
Cleared
Aug 10, 2026
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)
Hh Global Technology, Inc.
General Hospital
25d
Cleared
Aug 07, 2026
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)
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
General Hospital
140d
Cleared
Jul 29, 2026
Profoject™ Dual-Safety Pen Needles
CMT Health PTE., Ltd.
General Hospital
57d
Cleared
Jul 15, 2026
Profoject™ Pen Needles (Model A
CMT Health PTE., Ltd.
General Hospital
131d
Cleared
Jun 10, 2026
Profoject™ Safety Pen Needles
CMT Health PTE., Ltd.
General Hospital
86d
Cleared
Apr 16, 2026
Verisafe Safety Sterile Needles (SSN)
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital
107d
Cleared
Mar 25, 2026
Easydrip Classic Pen Needle
Sandstone Medical (Suzhou), Inc.
General Hospital
194d
Cleared
Mar 24, 2026
PRESSONE™
Nipro Medical Corporation
General Hospital
183d
Cleared
Mar 18, 2026
Safety Pen Needle
Ningbo Medsun Medical Co., Ltd.
General Hospital
120d
Cleared
Jan 06, 2026
Pen Needle
Hh Global Technology, Inc.
General Hospital
118d
Cleared
Nov 21, 2025
Pen Injector Needle 32.5
Terumo Corporation
General Hospital
259d
Cleared
Oct 16, 2025
Profoject™ Disposable Needle
CMT Health PTE., Ltd.
General Hospital
57d
Cleared
Jul 30, 2025
Intraosseous Infusion Needles
Spectrum Vascular
General Hospital
142d
Cleared
Jul 24, 2025
TSK SELECT™ Needle
Tsk Laboratory, Japan
General Hospital
174d
Cleared
Jul 08, 2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
Terumo Europe N.V.
General Hospital
60d
Cleared
May 29, 2025
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
Terumo Europe N.V.
General Hospital
220d
Cleared
Apr 18, 2025
FROG (Filter Removal of Glass)
Carrtech Corp
General Hospital
438d
Cleared
Apr 04, 2025
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
Terumo Europe N.V.
General Hospital
141d
Cleared
Apr 03, 2025
SureFine Pen Needle
Shina Med Corporation
General Hospital
29d
Cleared
Jan 10, 2025
Safety Winged Blood Collection Sets
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital
30d
Cleared
Jan 08, 2025
ACE Cannula
Ace Medical Industry Co., Ltd.
General Hospital
119d
Cleared
Sep 26, 2024
Verifine® Pen Needles
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital
23d
Cleared
Jul 02, 2024
ZIEN IO Intraosseous Access System
Zien Medical Technologies, Inc.
General Hospital
90d
About Product Code FMI - Regulatory Context
510(k) Submission Activity
695 total 510(k) submissions under product code FMI since 1976, with 695 receiving FDA clearance (average review time: 136 days).
Submission volume has declined in recent years - 23 submissions in the last 24 months compared to 32 in the prior period.
FDA 510(k) Review Time - FMI Product Code
FDA review times for FMI submissions have been consistent, averaging 128 days recently vs 136 days historically.
FMI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →