Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KRY · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
371 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862122 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | 1987-05-20 | 351 | 0 |
| K852016 | LASER PLATELETCAL/MULTIPLE | R&D Systems, Inc. | 1985-07-09 | 61 | 0 |
| K843910 | COULTER MEAN PLATELET VOLUME CALIBRATOR | Coulter Electronics, Inc. | 1985-01-07 | 96 | 0 |
| K840794 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | 1984-04-04 | 41 | 0 |
| K821851 | CONTROL DIAGNOSTICS PLATELET CONTROL | Immunogenetics | 1982-09-02 | 71 | 0 |
| K781601 | TEKNI-CAL | Streck Laboratories, Inc. | 1978-10-10 | 22 | 0 |
| K781133 | PC-CALIBRATOR | Streck Laboratories, Inc. | 1978-08-14 | 39 | 0 |
| K770143 | TQC CALIBRATION REFERENCE FOR PLATELETS | Technicon Instruments Corp. | 1978-01-30 | 371 | 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