Chrysalis Intelligence · Product Codes · FMI

FMI · Needle, Hypodermic, Single Lumen

General Hospital · 93 clearances · 52 unique sponsors

Device class
Class II
Regulation 880.5570
Total clearances
93
2020-02-03 → 2026-08-10
Last 12 months
12
Unique sponsors
52
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5570
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Promisemed Hangzhou Meditech Co., Ltd. 10 1 2026-04-16
Becton, Dickinson and Company 4 0 2022-12-28
CMT Health PTE., Ltd. 4 4 2026-07-29
Terumo Europe N.V. 4 0 2025-07-08
Sandstone Medical (Suzhou), Inc. 3 1 2026-03-25
Novo Nordisk, Inc. 3 0 2023-08-25
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. 3 0 2023-09-20
Wepon Medical Technology Co., Ltd. 3 0 2023-09-08
Ocuject, LLC 3 0 2023-11-27
Sichuan Prius Biotechnology Co., Ltd. 2 0 2022-10-04
Hantech Medical Device Co., Ltd. 2 0 2023-04-06
Pikdare Spa 2 0 2023-01-20
Tianjin Huahong Technology Co., Ltd. 2 0 2022-07-01
Zhejiang Kangkang Medical-Devices Co., Ltd. 2 0 2022-05-13
Ningbo Medsun Medical Co., Ltd. 2 1 2026-03-18
Berpu Medical Technology Co., Ltd. 2 0 2024-02-01
Altaviz, LLC 2 0 2023-07-27
Hh Global Technology, Inc. 2 2 2026-08-10
Htl-Strefa S.A 2 0 2020-10-15
Nipro Medical Corporation 2 1 2026-03-24
Zhejiang Kindly Medical Devices Co., Ltd. 2 0 2022-12-16
Teleflex Medical 2 0 2023-07-25
Shina Med Corporation 1 0 2025-04-03
Owen Mumford, Ltd. 1 0 2021-09-17
Zhejiang Kindly Medical Device Co., Ltd. 1 0 2023-12-12
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4207 HCPCS Syringe with needle, sterile 2 cc, each ✓ CMS-verified description High Needle, sterile, single lumen supply code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-10 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)
2026-08-07 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)
2026-07-29 K261829 CMT Health PTE., Ltd. Profoject™ Dual-Safety Pen Needles
2026-07-15 K260739 CMT Health PTE., Ltd. Profoject™ Pen Needles (Model A; Model B)
2026-06-10 K260855 CMT Health PTE., Ltd. Profoject™ Safety Pen Needles
2026-04-16 K254273 Promisemed Hangzhou Meditech Co., Ltd. Verisafe Safety Sterile Needles (SSN)
2026-03-25 K252908 Sandstone Medical (Suzhou), Inc. Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
2026-03-24 K253047 Nipro Medical Corporation PRESSONE™
2026-03-18 K253622 Ningbo Medsun Medical Co., Ltd. Safety Pen Needle
2026-01-06 K252886 Hh Global Technology, Inc. Pen Needle
2025-11-21 K250700 Terumo Corporation Pen Injector Needle 32.5
2025-10-16 K252631 CMT Health PTE., Ltd. Profoject™ Disposable Needle
2025-07-30 K250724 Spectrum Vascular Intraosseous Infusion Needles
2025-07-24 K250284 Tsk Laboratory, Japan TSK SELECT™ Needle
2025-07-08 K251447 Terumo Europe N.V. K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
2025-05-29 K243309 Terumo Europe N.V. 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
2025-04-18 K240355 Carrtech Corp FROG (Filter Removal of Glass)
2025-04-04 K243581 Terumo Europe N.V. K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
2025-04-03 K250658 Shina Med Corporation SureFine Pen Needle
2025-01-10 K243806 Promisemed Hangzhou Meditech Co., Ltd. Safety Winged Blood Collection Sets
2025-01-08 K242741 Ace Medical Industry Co., Ltd. ACE Cannula
2024-09-26 K242632 Promisemed Hangzhou Meditech Co., Ltd. Verifine® Pen Needles
2024-07-02 K240915 Zien Medical Technologies, Inc. ZIEN IO Intraosseous Access System
2024-02-01 K232165 Berpu Medical Technology Co., Ltd. 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
2023-12-12 K233037 Zhejiang Kindly Medical Device Co., Ltd. Sterile Hypodermic Needles for Single Use