Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KFX · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE | Vascutech, Inc. | 1993-07-22 | 78 | 6 |
| K833868 | IPOS G.L.P. SYSTEM | Ipos Luneburg | 1983-11-28 | 21 | 0 |
| K830285 | REGNELL HYDRAULIC FEMORAL PROTHESIS | Besco Financial Service | 1983-03-09 | 41 | 0 |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | American Mcgaw | 1982-12-30 | 156 | 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