FDA product code CAC: Apparatus, Autotransfusion
CAC is the FDA product code for apparatus, autotransfusion. It is a Class II device, regulated under 21 CFR 868.5830 and reviewed by the Cardiovascular panel. FDA has cleared 195 510(k) submissions under CAC, 6 in the last five years, from 73 different applicants. The average 510(k) review took 153 days (median 101); 85 days on average over the last three years. FDA has posted 89 recalls for CAC devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Autotransfusion |
| Device class | Class II |
| Regulation | 21 CFR 868.5830 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for CAC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 126 |
| 2018 | 2 | 142 |
| 2019 | 1 | 28 |
| 2020 | 1 | 180 |
| 2021 | 4 | 204 |
| 2022 | 1 | 154 |
| 2023 | 2 | 149 |
| 2024 | 3 | 85 |
Compare with all 510(k) review times · Search every CAC clearance
Top CAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Haemonetics Corp. | 15 | 2012-10-25 |
| Boehringer Laboratories | 12 | 2002-02-06 |
| Deknatel, Inc. | 11 | 1997-04-22 |
| Shiley, Inc. | 11 | 1991-11-27 |
| Atrium Medical Corp. | 9 | 2004-12-08 |
68 more applicants have CAC clearances. See the full list in Caduvo.
Most recent CAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241236 | Sorin Group Italia S.R.L. | XTRA Collection sets; XTRA Sequestration set X | 2024-08-16 | 106 |
| K240426 | Inquis Medical | Aventus Clot Management System | 2024-05-14 | 91 |
| K240584 | Sorin Group Italia S.R.L. | XTRA Autotransfusion System (with XTRA Bowl sets) | 2024-04-29 | 59 |
| K231782 | Inari Medical, Inc. | FlowSaver Blood Return System (80-101) | 2023-07-14 | 28 |
| K221483 | Inari Medical, Inc. | FlowSaver Blood Return System | 2023-02-17 | 270 |
Recalls for CAC devices
89 product recalls in 29 recall events; 7 initiated in the last five years and 9 still open. Most recent: 2023-12-13.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 24 |
| 2023 | 7 |
Frequently asked questions
What is FDA product code CAC?
CAC is the FDA product code for apparatus, autotransfusion. It is a Class II device, regulated under 21 CFR 868.5830 and reviewed by the Cardiovascular panel.
What device class is CAC?
Class II, regulation 21 CFR 868.5830. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAC?
Across 195 cleared submissions the average was 153 days from receipt to decision (median 101).
Which companies have the most CAC clearances?
Haemonetics Corp. (15); Boehringer Laboratories (12); Deknatel, Inc. (11); Shiley, Inc. (11); Atrium Medical Corp. (9).
Have CAC devices been recalled?
Yes: 89 product recalls across 29 recall events; the most recent began 2023-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code CAC
- Run a recall and safety report across every CAC manufacturer
- Watch product code CAC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times