Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KSA · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
161 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | Streck Laboratories, Inc. | 1994-12-15 | 161 | 0 |
| K897060 | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | 1990-01-02 | 15 | 0 |
| K881161 | TECH-CAL(TM)/MULTIPLE | R&D Systems, Inc. | 1988-05-02 | 45 | 0 |
| K864664 | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | Technicon Instruments Corp. | 1987-02-06 | 70 | 0 |
| K854823 | CBC-CAL/MULTIPLE | R&D Systems, Inc. | 1986-02-13 | 72 | 0 |
| K844708 | TRI-COUNT CALIBRATOR | Hematology Marketing Assoc. | 1985-03-05 | 92 | 0 |
| K813530 | HEMOTOLOGY CALIBRATOR | American Dade | 1982-02-22 | 67 | 0 |
| K813375 | HEMATOLOGY CALIBRATOR S-CAL | Coulter Electronics, Inc. | 1982-02-04 | 65 | 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