FDA product code · Cardiovascular · Class 2
DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
DWF is FDA's product code for "Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass": a Class 2 device classified under 21 CFR 870.4210, reviewed by the Cardiovascular panel.
510(k) review time for DWF
Across 33 510(k) clearances under DWF decided from 2018-01-01 to 2026-10-06, the median was 70 days from FDA receipt to decision. Half took between 30 and 217 days, and 80% were decided within 241 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 30 |
| Median | 70 |
| 75th percentile | 217 |
| 80th percentile | 241 |
| 90th percentile | 332 |
| Slowest | 447 |
| Year | Median days | n |
|---|---|---|
| 2018 | 30 | 5 |
| 2021 | 358 | 5 |
| 2026 (to 10-06, partial) | 81 | 6 |
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.
DWF in the public FDA record
| 510(k) clearances, all years | 401 |
|---|---|
| Device recalls | 563 |
| Establishment listings | 647 |
| GUDID device identifiers | 8,434 |
Counts of records, not of devices or events. Adverse event reports for DWF 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 DWF
2 FDA recognized consensus standards cite DWF, among them ISO 18193 First edition 2021-08; ISO 11658 First edition 2012-05-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-176 ISO 18193 First edition 2021-08 — Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
- 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.