FDA product code · Cardiovascular · Class 2
CAC: Apparatus, Autotransfusion
CAC is FDA's product code for "Apparatus, Autotransfusion": a Class 2 device classified under 21 CFR 868.5830, reviewed by the Cardiovascular panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for CAC
Across 14 510(k) clearances under CAC decided from 2018-01-01 to 2026-10-06, the median was 117 days from FDA receipt to decision. Half took between 37 and 181 days, and 80% were decided within 211 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 37 |
| Median | 117 |
| 75th percentile | 181 |
| 80th percentile | 211 |
| 90th percentile | 266 |
| Slowest | 476 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
CAC in the public FDA record
| 510(k) clearances, all years | 195 |
|---|---|
| Device recalls | 89 |
| Establishment listings | 160 |
Counts of records, not of devices or events. Adverse event reports for CAC are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite CAC
1 FDA recognized consensus standard cite CAC, 1 of them recognized only in part, among them IEC 61326-1 Edition 3.0 2020-10. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 19-42 IEC 61326-1 Edition 3.0 2020-10 (partial recognition) — Electrical equipment for measurement control and laboratory use - EMC requirements - Part 1: General requirements
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.