Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5830](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5830) → CAC — Apparatus, Autotransfusion # CAC · Apparatus, Autotransfusion _Anesthesiology · 21 CFR 868.5830 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC ## Overview - **Product Code:** CAC - **Device Name:** Apparatus, Autotransfusion - **Regulation:** [21 CFR 868.5830](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5830) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **Life-sustaining:** yes ## Identification An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 195) Showing 20 most recent of 195 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241236](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K241236.md) | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | Aug 16, 2024 | SESE | | [K240426](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K240426.md) | Aventus Clot Management System | Inquis Medical | May 14, 2024 | SESE | | [K240584](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K240584.md) | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | Apr 29, 2024 | SESE | | [K231782](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K231782.md) | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | Jul 14, 2023 | SESE | | [K221483](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K221483.md) | FlowSaver Blood Return System | Inari Medical, Inc. | Feb 17, 2023 | SESE | | [K221722](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K221722.md) | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Haemonetics Corporation | Nov 15, 2022 | SESE | | [K201305](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K201305.md) | 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 | Sep 3, 2021 | SESE | | [K210862](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K210862.md) | Hemafuse System | Sisu Global Health | Jul 29, 2021 | SESE | | [K210176](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K210176.md) | FlowSaver Blood Filter | Inari Medical | Jul 22, 2021 | SESE | | [K210089](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K210089.md) | CATSmart, Automated Blood Processing Autotransfusion System | Fresenius Kabi AG | Feb 11, 2021 | SESE | | [K193361](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K193361.md) | ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical, Inc. | Jun 1, 2020 | SESE | | [K192368](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K192368.md) | CATSmart | Fresenius Kabi AG | Sep 27, 2019 | SESE | | [K180831](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K180831.md) | CATSmart | Fresenius Kabi AG | Dec 10, 2018 | SESE | | [K181954](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K181954.md) | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | Aug 22, 2018 | SESE | | [K162423](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K162423.md) | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | Jan 3, 2017 | SESE | | [K160735](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K160735.md) | CATSmart | Fresenius Kabi AG | Sep 16, 2016 | SESE | | [K160197](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K160197.md) | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | May 24, 2016 | SESE | | [K140205](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K140205.md) | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Teleflexmedical, Inc. | Oct 23, 2014 | SESE | | [K140197](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K140197.md) | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Teleflexmedical, Inc. | Oct 21, 2014 | SESE | | [K131553](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K131553.md) | XTRA | Sorin Group Deutschland GmbH | Mar 21, 2014 | SESE | ## Top Applicants - Haemonetics Corp. — 15 clearances - Boehringer Laboratories — 12 clearances - Deknatel, Inc. — 11 clearances - Shiley, Inc. — 11 clearances - Atrium Medical Corp. — 9 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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