Product code FMI

Device name: Needle, Hypodermic, Single Lumen
Medical specialty: General Hospital
Device class: 2
Regulation number: 880.5570
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
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 VII...	Hh Global Technology, Inc.	2026-08-10
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-S...	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	2026-08-07
K261829	Profoject™ Dual-Safety Pen Needles	CMT Health PTE., Ltd.	2026-07-29
K260739	Profoject™ Pen Needles (Model A; Model B)	CMT Health PTE., Ltd.	2026-07-15
K260855	Profoject™ Safety Pen Needles	CMT Health PTE., Ltd.	2026-06-10
K254273	Verisafe Safety Sterile Needles (SSN)	Promisemed Hangzhou Meditech Co., Ltd.	2026-04-16
K252908	Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle	Sandstone Medical (Suzhou), Inc.	2026-03-25
K253047	PRESSONE™	Nipro Medical Corporation	2026-03-24
K253622	Safety Pen Needle	Ningbo Medsun Medical Co., Ltd.	2026-03-18
K252886	Pen Needle	Hh Global Technology, Inc.	2026-01-06
K250700	Pen Injector Needle 32.5	Terumo Corporation	2025-11-21
K252631	Profoject™ Disposable Needle	CMT Health PTE., Ltd.	2025-10-16
K250724	Intraosseous Infusion Needles	Spectrum Vascular	2025-07-30
K250284	TSK SELECT™ Needle	Tsk Laboratory, Japan	2025-07-24
K251447	K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)	Terumo Europe N.V.	2025-07-08
K243309	27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)	Terumo Europe N.V.	2025-05-29
K240355	FROG (Filter Removal of Glass)	Carrtech Corp	2025-04-18
K243581	K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)	Terumo Europe N.V.	2025-04-04
K250658	SureFine Pen Needle	Shina Med Corporation	2025-04-03
K243806	Safety Winged Blood Collection Sets	Promisemed Hangzhou Meditech Co., Ltd.	2025-01-10
K242741	ACE Cannula	Ace Medical Industry Co., Ltd.	2025-01-08
K242632	Verifine® Pen Needles	Promisemed Hangzhou Meditech Co., Ltd.	2024-09-26
K240915	ZIEN IO Intraosseous Access System	Zien Medical Technologies, Inc.	2024-07-02
K232165	Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles	Berpu Medical Technology Co., Ltd.	2024-02-01
K233037	Sterile Hypodermic Needles for Single Use	Zhejiang Kindly Medical Device Co., Ltd.	2023-12-12
K233343	SteriCap Safety Needle; VitreJect Safety Needle	Ocuject, LLC	2023-11-27
K230070	MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypode...	Promamedical, Inc.	2023-10-05
K230043	Insulin Pen Needle	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	2023-09-20
K230959	VitreJect® Needle; OcuSafe® Needle	Ocuject, LLC	2023-09-14
K231720	Sterile Hypodermic Needles for Single Use	Wepon Medical Technology Co., Ltd.	2023-09-08

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
06972857295677	contour comfort Pen Needle	Sandstone Medical (Suzhou) Inc.	2026-08-19
00015482234232	TechLITE PLUS PEN NEEDLES	Arkray USA, Inc.	2024-03-11
00015482273835	Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's	Arkray USA, Inc.	2020-01-21
00015482273538	Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10's	Arkray USA, Inc.	2020-01-21
00015482272838	Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100's	Arkray USA, Inc.	2020-01-21
00015482272531	Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100's	Arkray USA, Inc.	2020-01-21
00015482270308	Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's	Arkray USA, Inc.	2020-01-14
00015482235314	TechLITE PEN NEEDLES	Arkray USA, Inc.	2019-05-14
00015482275310	Assure® ID Safety Pen Needle 5mm x 31g 100's	Arkray USA, Inc.	2018-03-08
00015482275303	Assure® ID Safety Pen Needle 5mm x 30g 100's	Arkray USA, Inc.	2018-03-08
00015482230326	TechLITE Pen Needle 4mm x 32g Sample 10's	Arkray USA, Inc.	2018-02-26
B3091G0	Post Medical, Inc.	POST MEDICAL, INC.	2016-09-25
B3092G0	Post Medical, Inc.	POST MEDICAL, INC.	2016-09-25
B3092GY0	Post Medical, Inc.	POST MEDICAL, INC.	2016-09-25
B3093G0	Post Medical, Inc.	POST MEDICAL, INC.	2016-09-25
00015482232290	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482102913	ASSURE® ID Insulin 1cc Safety Syringe	Arkray USA, Inc.	2016-09-23
00015482102951	ASSURE® ID Insulin 0.5cc Safety Syringe	Arkray USA, Inc.	2016-09-23
00015482230296	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482238919	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482238322	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482238315	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482236328	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482236311	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482235918	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482230999	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482234928	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482234324	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
00015482232993	TechLITE PEN NEEDLES	Arkray USA, Inc.	2016-09-23
B3092201LPBWY0	Post Medical, Inc.	POST MEDICAL, INC.	2016-09-20

Product code FMI

Related 510(k) Records#

Related GUDID Devices#