CAC · Apparatus, Autotransfusion · Chrysalis Intelligence

Device class

Class II

Regulation 868.5830

Total clearances

2020-06-01 → 2024-08-16

Last 12 months

Unique sponsors

Classification details

Medical specialty

Anesthesiology

Review panel

Regulation number

868.5830

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Most recent
Inari Medical	3	2023-07-14
Sorin Group Italia S.R.L.	2	2024-08-16
Atrium Medical Corporation	1	2021-09-03
Fresenius Kabi AG	1	2021-02-11
Sisu Global Health	1	2021-07-29
Haemonetics Corporation	1	2022-11-15
Procell Surgical, Inc.	1	2020-06-01
Inquis Medical	1	2024-05-14

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
36830	CPT	—	Medium	Autotransfusion/blood recovery; procedure code for autotransfusion apparatus

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2024-08-16	K241236	Sorin Group Italia S.R.L.	XTRA Collection sets; XTRA Sequestration set X
2024-05-14	K240426	Inquis Medical	Aventus Clot Management System
2024-04-29	K240584	Sorin Group Italia S.R.L.	XTRA Autotransfusion System (with XTRA Bowl sets)
2023-07-14	K231782	Inari Medical, Inc.	FlowSaver Blood Return System (80-101)
2023-02-17	K221483	Inari Medical, Inc.	FlowSaver Blood Return System
2022-11-15	K221722	Haemonetics Corporation	Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
2021-09-03	K201305	Atrium Medical Corporation	Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
2021-07-29	K210862	Sisu Global Health	Hemafuse System
2021-07-22	K210176	Inari Medical	FlowSaver Blood Filter
2021-02-11	K210089	Fresenius Kabi AG	CATSmart, Automated Blood Processing Autotransfusion System
2020-06-01	K193361	Procell Surgical, Inc.	ProCell Surgical Sponge-Blood Recovery Unit