Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GIT · 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) |
|---|---|---|---|---|---|
| K890051 | BIOTRACK APTT CONTROLS | Biotrack, Inc. | 1989-02-23 | 48 | 0 |
| K881999 | PLATELIN(R) EXCEL L | Organon Teknika Corp. | 1988-08-17 | 97 | 0 |
| K880711 | CLP 0.02 M CALCIUM CHLORIDE SOLUTION. | Creative Laboratory Products, Inc. | 1988-03-18 | 25 | 0 |
| K820450 | THROMBOSCREEN | Pacific Hemostasis | 1982-03-26 | 36 | 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