FDA product code · Cardiovascular · Class 2
KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
KFM is FDA's product code for "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type": a Class 2 device classified under 21 CFR 870.4360, reviewed by the Cardiovascular panel.
510(k) review time for KFM
Across 14 510(k) clearances under KFM decided from 2018-01-01 to 2026-10-06, the median was 143 days from FDA receipt to decision. Half took between 37 and 365 days, and 80% were decided within 427 days. These are past clearances, not a forecast for a new submission.
| Fastest | 16 |
|---|---|
| 25th percentile | 37 |
| Median | 143 |
| 75th percentile | 365 |
| 80th percentile | 427 |
| 90th percentile | 504 |
| Slowest | 672 |
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.
KFM in the public FDA record
| 510(k) clearances, all years | 84 |
|---|---|
| Device recalls | 40 |
| Establishment listings | 117 |
| GUDID device identifiers | 1,812 |
Counts of records, not of devices or events. Adverse event reports for KFM 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 KFM
4 FDA recognized consensus standards cite KFM, among them ASTM F1830-19 (Reapproved 2024); ASTM F1841-19; ISO 11658 First edition 2012-05-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-164 ASTM F1830-19 (Reapproved 2024) — Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps
- 3-165 ASTM F1841-19 — Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
- 3-183 ISO 11658 First edition 2012-05-15 — Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
- 3-199 ASTM F1841-25 — Standard Practice for Assessment of Hemolysis in Blood Pumps
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.