Product code CAC— Anesthesiology
CATSmart
- Classification name
- Apparatus, Autotransfusion
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Total cleared
- 195
- First cleared
- Most recent
Market context for product code CAC
FDA has cleared devices under product code CAC between 1977 and 2024, filed by 73 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2011
- 2010
- 2008
Top applicants under product code CAC
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code CAC
1–100 of 195- K241236 — XTRA Collection sets; XTRA Sequestration set X
- K240426 — Aventus Clot Management System
- K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)
- K231782 — FlowSaver Blood Return System (80-101)
- K221483 — FlowSaver Blood Return System
- K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
- K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- K210862 — Hemafuse System
- K210176 — FlowSaver Blood Filter
- K210089 — CATSmart, Automated Blood Processing Autotransfusion System
- K193361 — ProCell Surgical Sponge-Blood Recovery Unit
- K192368 — CATSmart
- K180831 — CATSmart
- K181954 — autoLog IQ Autotransfusion System
- K162423 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
- K160735 — CATSmart
- K160197 — Haemonetics Cell Saver Elite Autotransfusion System
- K140205 — PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
- K140197 — PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
- K131553 — XTRA
- K130043 — PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K120953 — PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K122262 — ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
- K120586 — CELL SAVER ELITE
- K112245 — XTRA
- K110782 — XVAC
- K101907 — HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
- K103202 — PREASSEMBLED SURGICAL WASH SET
- K101586 — XTRA AUTOTRANSFUSION SYSTEM
- K093535 — AUTOLOG AUTOTRANSFUSION SYSTEM
- K082923 — PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
- K060482 — CYTORI CELUTION CELL CONCENTRATION DEVICE
- K053000 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
- K043127 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
- K043140 — EXPRESS AND OASIS CHEST DRAIN
- K041525 — HEMOVAC BLOOD REINFUSION SYSTEM
- K031554 — S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K022167 — PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
- K024097 — SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
- K022489 — SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
- K020647 — DIDECO ELECTA
- K022348 — ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
- K012406 — ACCESS SEQUESTRATION SYSTEM
- K014187 — AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
- K014083 — HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
- K012178 — FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
- K993581 — HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
- K992723 — ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
- K991986 — COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
- K983022 — SMARTCELL PROCESSING SYSTEM
- K982660 — ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
- K984233 — C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
- K982712 — RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
- K982650 — AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
- K982241 — BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
- K982755 — MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
- K972894 — AUTOTRANSFUSION APPARTUS (AUTOLOG)
- K974897 — COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
- K963758 — CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
- K963759 — DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
- K970714 — STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
- K970857 — ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
- K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
- K973627 — STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
- K971274 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
- K963850 — PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K962475 — ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
- K962689 — COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP)
- K964070 — DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
- K960734 — HAEMOCELL SYSTEM 350 OR S350
- K963098 — PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
- K960006 — C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
- K955010 — AUTOVAC BP SYSTE, 2000 SERIES
- K942844 — LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
- K951592 — BETATRANS I AND II
- K953118 — CARACELL
- K952224 — STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
- K945775 — BOEHRINGER AUTOVAC(R) 7900 SERIES
- K944232 — AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
- K942791 — ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
- K936220 — DIDECO VACUUM PUMP
- K940519 — DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM
- K931899 — DAVOL ATS
- K926338 — PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
- K932093 — AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
- K933960 — PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
- K940678 — AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
- K932890 — CELL SAVER 5 SYSTEM
- K933625 — BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
- K931552 — DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
- K931106 — BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
- K925827 — IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
- K920618 — AUTOTRANSFUSION SUCTION SET
- K913177 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
- K913247 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
- K915130 — MAT MEMBRANE AUTOTRANSFUSION SYSTEM
- K924894 — AUTOVAC 7900 SERIES
- K920273 — HEMOVAC AUTOTRANSFUSION SYSTEM
- K914119 — DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
- K923016 — AUTOLOGOUS BLOOD COLLECTION SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.