Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GJP · 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) |
|---|---|---|---|---|---|
| K880608 | MSI-PC | Medical Specialties, Inc. | 1988-03-21 | 38 | 0 |
| K823930 | HEMATOLOGY QUALITY CONTROL MIXTURE | Fisher Scientific Co., LLC | 1983-02-01 | 34 | 0 |
| K771588 | PLATELET CONTROLS NORMAL & ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-25 | 7 | 0 |
| K770655 | LATELET DETERMIBATION KIT, UL 800 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 | 79 | 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