Chrysalis Intelligence · Product Codes · FMF

FMF · Unclassified

115 clearances · 76 unique sponsors

Device class
Regulation —
Total clearances
115
2020-01-06 → 2026-08-14
Last 12 months
13
Unique sponsors
76
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Promisemed Hangzhou Meditech Co., Ltd. 7 1 2025-12-10
Sol-Millennium Medical, Inc. 5 1 2026-06-18
Becton, Dickinson and Company 5 0 2025-07-29
Instylla, Inc. 3 1 2025-12-22
Anhui Tiankang Medical Technology Co., Ltd. 3 0 2022-07-14
CMT Health PTE., Ltd. 3 2 2026-06-12
Surgentec 3 0 2025-02-05
Berpu Medical Technology Co., Ltd. 3 0 2022-11-03
International Medical Industries, Inc. 2 0 2024-09-04
Set Medikal Sanayi VE Ticaret Anonim Sirketi 2 0 2021-05-14
Wuxi Nest Biotechnology Co., Ltd. 2 0 2024-08-15
Chirana T. Injecta 2 0 2024-12-24
Hlb Lifescience Co., Ltd. 2 1 2026-05-21
Azur Medical Company, Inc. 2 0 2022-01-27
Prosidyan, Inc. 2 0 2025-06-24
Shandong Weigao Group Medical Polymer Co., Ltd. 2 0 2023-03-23
Shina Med Corporation 2 1 2025-10-15
Avitus Orthopaedics, Inc. 2 0 2023-07-17
Sichuan Prius Biotechnology Co., Ltd. 2 0 2022-10-04
Lifelong Meditech Private Limited 2 0 2023-07-18
Jiangsu Caina Medical Co.,Ltd 2 0 2022-07-21
Ocuject, LLC 2 0 2021-10-13
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. 2 0 2024-03-19
Perfect Medical Industry (Vn) Co., Ltd. 1 0 2024-06-12
Nanum Company Co., Ltd. 1 0 2021-01-17
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
A4206 HCPCS Syringe with needle, sterile, 1 cc or less, each ✓ CMS-verified description High Syringe with needle, sterile, supply code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-14 K253747 Jiangsu Enjosim Medical Technology Co., Ltd. Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
2026-07-13 K260208 embecta Medical II, LLC Ultra-Fine™ SAFETY Insulin Syringe
2026-06-18 K253110 Sol-Millennium Medical, Inc. Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
2026-06-12 K260514 CMT Health PTE., Ltd. Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle
2026-05-21 K253112 Hlb Lifescience Co., Ltd. Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
2026-04-17 K252279 Chirana T.Injecta,A.S. Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
2026-02-23 K253068 CMT Health PTE., Ltd. Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe
2025-12-22 K253769 Instylla, Inc. Instylla Delivery Kit
2025-12-17 K252518 Duopross Meditech Corporate DuoprossTM Smart Cap (Type I)
2025-12-12 K251089 Exelint International, Co. EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
2025-12-10 K250192 Promisemed Hangzhou Meditech Co., Ltd. Verisafe Safety Retractable Insulin Syringes
2025-11-04 K250853 Merit Medical Systems, Inc. Merit Syringe
2025-10-15 K250510 Shina Med Corporation Sure-Fine Insulin Syringes
2025-08-22 K243660 Cardinalhealth Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
2025-07-29 K251350 Becton, Dickinson and Company BD Plastipak™ Syringe
2025-07-25 K252033 CMT Health PTE., Ltd. Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
2025-07-03 K250733 Bimed Teknik Aletler Sanayi & Ticaret A.S. 3DOSE 1ml Syringe
2025-06-24 K251648 Prosidyan, Inc. GPS Advanced; GPS Advanced Cannula
2025-04-24 K250262 Go-Pen Aps GO-PEN®
2025-02-05 K243580 SurGenTec, LLC GraftGun Universal Graft Delivery System (GDS)
2024-12-24 K242434 Chirana T. Injecta Insulin Syringes
2024-12-23 K241856 Hlb Lifescience Co., Ltd. Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
2024-10-22 K242099 Sol-Millennium Medical, Inc. Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle
2024-09-20 K241821 Sol-Millennium Medical, Inc. Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
2024-09-04 K231095 International Medical Industries, Inc. Tamper Evident Cap