FMF · Syringe, Piston · Chrysalis Intelligence

Device class

Class II

Regulation 880.5860

Total clearances

117

2020-01-06 → 2026-08-26

Last 12 months

Unique sponsors

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.5860

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.	6	2	2026-08-25
Becton, Dickinson and Company	5	0	2025-07-29
Surgentec	4	1	2026-08-26
CMT Health PTE., Ltd.	3	2	2026-06-12
Anhui Tiankang Medical Technology Co., Ltd.	3	0	2022-07-14
Berpu Medical Technology Co., Ltd.	3	0	2022-11-03
Instylla, Inc.	3	1	2025-12-22
Azur Medical Company, Inc.	2	0	2022-01-27
Prosidyan, Inc.	2	0	2025-06-24
Ocuject, LLC	2	0	2021-10-13
Shandong Weigao Group Medical Polymer Co., Ltd.	2	0	2023-03-23
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	2	0	2024-03-19
Lifelong Meditech Private Limited	2	0	2023-07-18
Sichuan Prius Biotechnology Co., Ltd.	2	0	2022-10-04
Set Medikal Sanayi VE Ticaret Anonim Sirketi	2	0	2021-05-14
Chirana T. Injecta	2	0	2024-12-24
International Medical Industries, Inc.	2	0	2024-09-04
Avitus Orthopaedics, Inc.	2	0	2023-07-17
Jiangsu Caina Medical Co.,Ltd	2	0	2022-07-21
Shina Med Corporation	2	1	2025-10-15
Wuxi Nest Biotechnology Co., Ltd.	2	0	2024-08-15
Hlb Lifescience Co., Ltd.	2	1	2026-05-21
Perfect Medical Industry (Vn) Co., Ltd.	1	0	2024-06-12
Bone Solutions, Inc.	1	0	2020-02-18

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.

Code	Type	Description	Confidence	Rationale
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

Date	K-number	Sponsor	Device
2026-08-26	K262581	SurGenTec, LLC	GraftGun Universal Graft Delivery System (GDS®)
2026-08-25	K252184	Sol-Millennium Medical, Inc.	SOL-M Luer Lock Syringe with Exchangeable Needle Tray
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