LHI · Set, I.V. Fluid Transfer · Chrysalis Intelligence

Device class

Class II

Regulation 880.5440

Total clearances

2020-04-20 → 2026-06-12

Last 12 months

Unique sponsors

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.5440

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
West Pharma. Services IL, Ltd.	5	0	2024-01-19
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	4	1	2026-06-05
Sfm Medical Devices GmbH	2	0	2024-09-06
Icu Medical	2	0	2025-01-22
Yukon Medical, LLC	2	0	2025-03-21
B.Braun Medical, Inc.	1	0	2020-12-09
Epic Medical Pte. , Ltd.	1	1	2026-06-12
Omnicell, Inc.	1	0	2022-04-24
Asset Medikal Tasarim Sanayi VE Ticaret A.S.	1	0	2024-06-26
Takeda Pharmaceuticals	1	0	2025-07-18
Fresenius Kabi AG	1	0	2022-06-01
Care Fusion	1	0	2024-03-06
West Pharmaceutical Services, Inc.	1	0	2024-05-03
Sol-Millennium Medical Group	1	0	2021-11-03
Avenir Performance Européenne Medical (Apem)	1	0	2022-06-21
Ipax, Inc.	1	0	2021-05-04
West Pharmaceutical Services Az, Inc.	1	0	2020-10-21
Shanghai Lingfu Technology Co., Ltd.	1	0	2023-10-06
Microtek Medical, LLC	1	1	2025-09-16
Aea Srl	1	0	2021-09-27
Asset Medikal	1	1	2025-10-14
Advcare Medical	1	0	2022-08-19
Medline Industries, LP	1	1	2025-10-24

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
A4211	HCPCS	Supplies for self-administered injections ✓ CMS-verified description	Medium	HCPCS supply code for IV infusion set/tubing
86000	CPT	—	Low	I.V. transfer sets are typically consumable supplies; may not have dedicated procedure code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-12	K252987	Epic Medical Pte. , Ltd.	ADRx Admixture Device
2026-06-05	K260301	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter
2025-10-24	K250345	Medline Industries, LP	Medline Bag Decanter
2025-10-14	K251715	Asset Medikal	FlowArt® Vial Access Device Vented
2025-09-16	K251676	Microtek Medical, LLC	Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
2025-07-18	K243404	Takeda Pharmaceuticals	HyHub and HyHub Duo Vial Access Devices
2025-03-21	K240761	Yukon Medical, LLC	Arisure® Closed Male Luer with Spike Adapter (YM060)
2025-01-22	K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device
2024-12-06	K243486	Yukon Medical, LLC	SmartSiteTM Vented Vial Access Device
2024-09-06	K241976	Sfm Medical Devices GmbH	nextaro® va, 15mm, 5µm
2024-07-26	K233287	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vent Vial Adapter
2024-06-26	K232987	Asset Medikal Tasarim Sanayi VE Ticaret A.S.	FlowArt Valve for Vial Access
2024-05-03	K240940	West Pharmaceutical Services, Inc.	Vial2Bag Advanced® 20mm Admixture Device
2024-05-01	K233284	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter with Filter
2024-04-16	K240748	Sfm Medical Devices GmbH	nextaro® v, 20/20
2024-03-06	K233021	Care Fusion	BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device
2024-01-19	K231071	West Pharma. Services IL, Ltd.	Mix2Vial® Transfer Device
2023-12-14	K232875	West Pharma. Services IL, Ltd.	Vial Adapter 20mm
2023-12-01	K230988	West Pharma. Services IL, Ltd.	Vial2Bag Advanced® 13mm Admixture Device
2023-10-06	K232055	Shanghai Lingfu Technology Co., Ltd.	Vial Adapter
2023-05-22	K230464	West Pharma. Services IL, Ltd.	MixJect® Transfer Device
2023-03-10	K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter
2022-08-31	K213513	West Pharma. Services IL, Ltd.	Vented Vial Adapter 20mm
2022-08-19	K212525	Advcare Medical	Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
2022-06-21	K220856	Avenir Performance Européenne Medical (Apem)	Vial Adapter Ø13mm