Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GKK — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
96 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896922 | RAICHEM TM HEMOGLOBIN REAGENT | Reagents Applications, Inc. | 1990-01-25 | 45 | 0 |
| K894951 | MODIFIED HEMOGLOBIN REAGENT SET | Macomb Biotechnology, Inc. | 1989-10-24 | 96 | 0 |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | Kvm Technologies, Inc. | 1988-10-12 | 22 | 0 |
| K821202 | HEMOGLOBIN REAGENT SET | Omega Medical Electronics | 1982-05-24 | 27 | 0 |
| K771716 | CYMET-PLUS | J.T. Baker Chemical Co. | 1977-09-20 | 8 | 0 |
| K771090 | UNIPAK HEMOGLOBIN | Harleco | 1977-07-11 | 25 | 0 |
| K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) | Hycel, Inc. | 1977-07-05 | 64 | 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