FDA product code · Cardiovascular · Class 2
DTR: Heat-Exchanger, Cardiopulmonary Bypass
DTR is FDA's product code for "Heat-Exchanger, Cardiopulmonary Bypass": a Class 2 device classified under 21 CFR 870.4240, reviewed by the Cardiovascular panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for DTR
Across 10 510(k) clearances under DTR decided from 2018-01-01 to 2026-10-06, the median was 128 days from FDA receipt to decision. Half took between 114 and 194 days, and 80% were decided within 230 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 114 |
| Median | 128 |
| 75th percentile | 194 |
| 80th percentile | 230 |
| 90th percentile | 316 |
| Slowest | 462 |
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.
DTR in the public FDA record
| 510(k) clearances, all years | 91 |
|---|---|
| Device recalls | 33 |
| Establishment listings | 89 |
Counts of records, not of devices or events. Adverse event reports for DTR 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 DTR
1 FDA recognized consensus standard cite DTR, among them ISO 11658 First edition 2012-05-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-183 ISO 11658 First edition 2012-05-15 — Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.