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 Boehringer Laboratories, Deknatel, Inc. and Shiley, 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
Cleared
Aug 16, 2024
XTRA Collection sets
Sorin Group Italia S.R.L.
Cardiovascular
106d
Cleared
May 14, 2024
Aventus Clot Management System
Inquis Medical
Cardiovascular
91d
Cleared
Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
Sorin Group Italia S.R.L.
Cardiovascular
59d
Cleared
Jul 14, 2023
FlowSaver Blood Return System (80-101)
Inari Medical, Inc.
Cardiovascular
28d
Cleared
Feb 17, 2023
FlowSaver Blood Return System
Inari Medical, Inc.
Cardiovascular
270d
Cleared
Nov 15, 2022
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
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
Atrium Medical Corporation
Cardiovascular
476d
Cleared
Jul 29, 2021
Hemafuse System
Sisu Global Health
Cardiovascular
128d
Cleared
Jul 22, 2021
FlowSaver Blood Filter
Inari Medical
Cardiovascular
181d
Cleared
Feb 11, 2021
CATSmart, Automated Blood Processing Autotransfusion System
Fresenius Kabi AG
Cardiovascular
29d
Cleared
Jun 01, 2020
ProCell Surgical Sponge-Blood Recovery Unit
Procell Surgical, Inc.
Cardiovascular
180d
Cleared
Sep 27, 2019
CATSmart
Fresenius Kabi AG
Cardiovascular
28d
Cleared
Dec 10, 2018
CATSmart
Fresenius Kabi AG
Cardiovascular
255d
Cleared
Aug 22, 2018
autoLog IQ Autotransfusion System
Medtronic Perfusion Systems
Cardiovascular
30d
Cleared
Oct 23, 2014
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
Teleflexmedical, Inc.
Anesthesiology
269d
Cleared
Oct 21, 2014
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
Teleflexmedical, Inc.
Anesthesiology
267d
Cleared
Feb 12, 2013
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
Teleflexmedical, Inc.
Anesthesiology
35d
Cleared
Sep 06, 2011
XTRA
Sorin Group Italia S.R.L.
Anesthesiology
33d
Cleared
Apr 07, 2011
XVAC
Sorin Group Italia S.R.L.
Anesthesiology
17d
Cleared
Nov 23, 2010
PREASSEMBLED SURGICAL WASH SET
Sorin Group Italia S.R.L.
Anesthesiology
22d
Cleared
Oct 05, 2010
XTRA AUTOTRANSFUSION SYSTEM
Sorin Group Italia S.R.L.
Anesthesiology
120d
Cleared
Mar 22, 2010
AUTOLOG AUTOTRANSFUSION SYSTEM
Medtronic, Inc.
Anesthesiology
126d
Cleared
Dec 08, 2004
EXPRESS AND OASIS CHEST DRAIN
Atrium Medical Corp.
Anesthesiology
23d
Cleared
Oct 14, 2004
HEMOVAC BLOOD REINFUSION SYSTEM
Zimmer, Inc.
Anesthesiology
128d
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 Anesthesiology panel. Browse all Anesthesiology devices →