CAC · Class II · 21 CFR 868.5830

FDA Product Code CAC: Apparatus, Autotransfusion

Recovering the patient's own shed blood reduces transfusion requirements during surgery. FDA product code CAC covers autotransfusion apparatus used in operative and post-operative blood recovery.

These systems collect, filter, wash, and reinfuse the patient's own shed blood during cardiac, vascular, and orthopedic surgery. Autotransfusion reduces allogeneic blood exposure and its associated risks, including transfusion reactions and infection transmission.

CAC devices are Class II medical devices, regulated under 21 CFR 868.5830 and reviewed by the FDA Hematology panel.

Leading manufacturers include Baxter Healthcare Corp, Fresenius Kabi AG and Inari Medical, Inc..

195
Total
195
Cleared
153d
Avg days
1977
Since
Declining activity - 1 submissions in the last 2 years vs 5 in the prior period
Review times improving: avg 106d recently vs 154d historically

FDA 510(k) Cleared Apparatus, Autotransfusion Devices (Product Code CAC)

195 devices
1–24 of 195
Cleared Aug 16, 2024
XTRA Collection sets
K241236
Sorin Group Italia S.R.L.
Cardiovascular · 106d
Cleared May 14, 2024
Aventus Clot Management System
K240426
Inquis Medical
Cardiovascular · 91d
Cleared Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584
Sorin Group Italia S.R.L.
Cardiovascular · 59d
Cleared Jul 14, 2023
FlowSaver Blood Return System (80-101)
K231782
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Feb 17, 2023
FlowSaver Blood Return System
K221483
Inari Medical, Inc.
Cardiovascular · 270d
Cleared Nov 15, 2022
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722
Haemonetics Corporation
Cardiovascular · 154d
Cleared Sep 03, 2021
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
K201305
Atrium Medical Corporation
Cardiovascular · 476d
Cleared Jul 29, 2021
Hemafuse System
K210862
Sisu Global Health
Cardiovascular · 128d
Cleared Jul 22, 2021
FlowSaver Blood Filter
K210176
Inari Medical
Cardiovascular · 181d
Cleared Feb 11, 2021
CATSmart, Automated Blood Processing Autotransfusion System
K210089
Fresenius Kabi AG
Cardiovascular · 29d
Cleared Jun 01, 2020
ProCell Surgical Sponge-Blood Recovery Unit
K193361
Procell Surgical, Inc.
Cardiovascular · 180d
Cleared Sep 27, 2019
CATSmart
K192368
Fresenius Kabi AG
Cardiovascular · 28d
Cleared Dec 10, 2018
CATSmart
K180831
Fresenius Kabi AG
Cardiovascular · 255d
Cleared Aug 22, 2018
autoLog IQ Autotransfusion System
K181954
Medtronic Perfusion Systems
Cardiovascular · 30d
Cleared Oct 14, 2004
HEMOVAC BLOOD REINFUSION SYSTEM
K041525
Zimmer, Inc.
Anesthesiology · 128d
Cleared Feb 23, 1996
CARACELL
K953118
Medtronic Vascular
Anesthesiology · 235d
Cleared Apr 15, 1994
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678
Baxter Healthcare Corp
Anesthesiology · 65d
Cleared Aug 29, 1990
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
K900483
Baxter Healthcare Corp
Anesthesiology · 209d
Cleared Aug 01, 1989
PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS
K893578
Baxter Healthcare Corp
Anesthesiology · 84d
Cleared Oct 09, 1987
DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT
K872927
C.R. Bard, Inc.
Anesthesiology · 74d

About Product Code CAC - Regulatory Context

510(k) Submission Activity

195 total 510(k) submissions under product code CAC since 1977, with 195 receiving FDA clearance (average review time: 153 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 5 in the prior period.

FDA 510(k) Review Time - CAC Product Code

Recent submissions under CAC have taken an average of 106 days to reach a decision - down from 154 days historically, suggesting improved FDA processing for this classification.

CAC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →