FDA product code · Cardiovascular · Class 2
DTZ: Oxygenator, Cardiopulmonary Bypass
DTZ is FDA's product code for "Oxygenator, Cardiopulmonary Bypass": a Class 2 device classified under 21 CFR 870.4350, reviewed by the Cardiovascular panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for DTZ
Across 33 510(k) clearances under DTZ decided from 2018-01-01 to 2026-10-06, the median was 137 days from FDA receipt to decision. Half took between 88 and 269 days, and 80% were decided within 289 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 88 |
| Median | 137 |
| 75th percentile | 269 |
| 80th percentile | 289 |
| 90th percentile | 426 |
| Slowest | 706 |
| Year | Median days | n |
|---|---|---|
| 2019 | 90 | 5 |
| 2020 | 93 | 5 |
| 2021 | 336 | 5 |
| 2023 | 145 | 5 |
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.
DTZ in the public FDA record
| 510(k) clearances, all years | 254 |
|---|---|
| Device recalls | 107 |
| Establishment listings | 201 |
| GUDID device identifiers | 1,665 |
Counts of records, not of devices or events. Adverse event reports for DTZ 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 DTZ
3 FDA recognized consensus standards cite DTZ, among them ISO 7199 Third edition 2016-11-15; ISO 11658 First edition 2012-05-15; ISO 7199 Fourth edition 2024-09. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-150 ISO 7199 Third edition 2016-11-15 — Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
- 3-183 ISO 11658 First edition 2012-05-15 — Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
- 3-194 ISO 7199 Fourth edition 2024-09 — Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.