FPA · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-02-20 → 2026-06-03

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Baxter Healthcare Corporation	6	0	2025-03-14
B.Braun Medical, Inc.	5	0	2025-07-24
Quest Medical, Inc.	4	0	2024-12-18
Asset Medikal Tasarim As.	4	0	2022-09-26
Sichuan Prius Biotechnology Co., Ltd.	3	0	2022-11-21
Np Medical	3	1	2025-12-04
Bq Plus Medical Co., Ltd.	3	0	2024-08-22
Epic Medical Pte. , Ltd.	3	1	2025-08-29
Care Fusion	3	0	2023-07-21
Deka Research and Development	2	1	2026-06-03
Innovative Health Sciences, LLC	2	0	2024-03-01
Puracath Medical, Inc.	2	1	2026-02-12
Medcaptain Life Science Co., Ltd.	2	0	2023-12-01
Fresenius Kabi	2	0	2023-06-16
Amsino International, Inc.	2	1	2026-05-04
Icu Medical, Inc.	1	0	2025-06-05
Unomedical A/S	1	0	2021-07-16
Asset Medikal Tasarim San Tic As.	1	0	2023-01-20
Shandong Zhushi Pharmaceutical Group Co., Ltd.	1	0	2024-05-10
Carefusion (Bd)	1	1	2025-10-30
Shandong Ande Healthcare Apparatus Co., Ltd.	1	0	2024-04-12
Ivenix, Inc.	1	0	2021-11-10
Jiangsu Kangbao Medical Equipment Co., Ltd.	1	0	2020-07-28
Pfm Medical, Inc.	1	0	2025-05-02
Tandem Diabetes Care	1	0	2025-08-06

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
36640	CPT	—	Medium	Vascular access procedure; intravascular administration sets are often billed with vascular access codes
A4221	HCPCS	Supplies for maintenance of non-insulin drug infusion catheter, per week (list drugs separately) ✓ CMS-verified description	Medium	Supply code for IV infusion supplies including administration sets

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-03	K261530	Deka Research and Development	iiSure Infusion Set
2026-05-04	K252543	Amsino International, Inc.	AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
2026-02-12	K251375	Puracath Medical, Inc.	PuraCath Firefly Needleless Connector IT (9005)
2025-12-04	K251257	Np Medical	nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
2025-10-30	K250325	Carefusion (Bd)	BD Alaris Pump Infusion Set
2025-08-29	K251814	Epic Medical Pte. , Ltd.	EZ IV Administration Set
2025-08-06	K251854	Tandem Diabetes Care	SteadiSet infusion set
2025-08-01	K243841	Deka Research and Development	Sparta Infusion Set for Insulin
2025-07-24	K243392	B.Braun Medical, Inc.	Infusomat® Space Volumetric Infusion Pump Administration Sets
2025-06-05	K250616	Icu Medical, Inc.	Clave Neutral-Displacement Needlefree Connectors
2025-05-09	K242692	Capillary Biomedical, LLC	SteadiSet Infusion Set
2025-05-02	K242763	Pfm Medical, Inc.	JetCan® Pro Safety Huber Needle
2025-03-14	K243529	Baxter Healthcare Corporation	Solution Administration Sets
2025-02-28	K242339	Baxter Healthcare Corporation	Intravascular Extension Sets and Accessories
2024-12-18	K241058	Quest Medical, Inc.	Lyka® PORT Needle Free Access Device (4170Y)
2024-09-20	K234129	Ecomed Solutions, LLC	Ecomed Disposable Administration Sets
2024-08-22	K242126	Bq Plus Medical Co., Ltd.	I.V. Administration Set
2024-05-10	K232475	Shandong Zhushi Pharmaceutical Group Co., Ltd.	Disposable infusion set with needle
2024-04-12	K222766	Shandong Ande Healthcare Apparatus Co., Ltd.	Disposable Extension Set
2024-03-01	K232328	Innovative Health Sciences, LLC	Insignis Syringe Infusion System
2024-01-03	K231707	Q For Plastic Industries	ResQ Administration Set
2023-12-01	K230528	Medcaptain Life Science Co., Ltd.	Extension Set
2023-11-09	K222780	Lily Medical Corporation	LILY Extension Tube and Needleless Connector
2023-11-03	K230343	Epic Medical Pte. , Ltd.	ProSeal Closed System Administration Set
2023-07-21	K221327	Care Fusion	BD Alaris Pump Infusion Sets

FPA · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances