Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KDK · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053169 | RM3 RENAL PRESERVATION SYSTEM | Waters Instruments, Inc. | 2006-01-17 | 64 | 0 |
| K911577 | HYPOTRANS MODEL 750 | Martin Mclane Medical | 1992-07-08 | 457 | 0 |
| K801899 | KEITHLEY LYMPHOCYTE DEPLETION CART | Keithley Development Co. | 1980-09-26 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda