FDA product code FMI: Needle, Hypodermic, Single Lumen

FMI is the FDA product code for needle, hypodermic, single lumen. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 694 510(k) submissions under FMI, 67 in the last five years, from 387 different applicants. The average 510(k) review took 136 days (median 91); 124 days on average over the last three years. FDA has posted 311 recalls for FMI devices, 10 initiated in the last five years.

Classification

Field	Value
Device name	Needle, Hypodermic, Single Lumen
Device class	Class II
Regulation	21 CFR 880.5570
Review panel	HO — General Hospital
Medical specialty	General Hospital
Premarket route	510(k)
Third-party 510(k) review eligible	Yes

510(k) clearances per year for FMI

Year	Clearances	Avg. review days
2017	8	203
2018	20	212
2019	12	178
2020	10	229
2021	18	185
2022	23	202
2023	18	174
2024	3	103
2025	11	152
2026	12	117

Compare with all 510(k) review times · Search every FMI clearance

Top FMI applicants

Applicant	Clearances	Latest
Bd Becton Dickinson Vacutainer Systems Preanalytic	20	2001-02-01
Terumo Europe N.V.	15	2025-07-08
Promisemed Hangzhou Meditech Co., Ltd.	13	2026-08-25
Vidacare Corporation	13	2014-02-11
Sherwood Medical Co.	13	1996-12-23

382 more applicants have FMI clearances. See the full list in Caduvo.

Most recent FMI clearances

510(k)	Applicant	Device	Decision date	Review days
K261266	PENTAMASTER MEDIQ SDN BHD	MOWANA Auto Duo	2026-09-17	154
K261719	Promisemed Hangzhou Meditech Co., Ltd.	Promisemed X-Safety Pen Needle	2026-08-25	91
K262427	Hh Global Technology, Inc.	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)	2026-08-10	25
K260933	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	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)	2026-08-07	140
K261829	CMT Health PTE., Ltd.	Profoject Dual-Safety Pen Needles	2026-07-29	57

Recalls for FMI devices

311 product recalls in 78 recall events; 10 initiated in the last five years and 22 still open. Most recent: 2026-07-30.

Year	Recalls
2017	41
2018	4
2019	33
2020	7
2021	12
2022	1
2023	3
2024	3
2025	2
2026	1

Frequently asked questions

What is FDA product code FMI?

FMI is the FDA product code for needle, hypodermic, single lumen. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.

What device class is FMI?

Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).

How long does a 510(k) take for product code FMI?

Across 694 cleared submissions the average was 136 days from receipt to decision (median 91).

Which companies have the most FMI clearances?

Bd Becton Dickinson Vacutainer Systems Preanalytic (20); Terumo Europe N.V. (15); Promisemed Hangzhou Meditech Co., Ltd. (13); Vidacare Corporation (13); Sherwood Medical Co. (13).

Have FMI devices been recalled?

Yes: 311 product recalls across 78 recall events; the most recent began 2026-07-30.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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