Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KSE — 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) |
|---|---|---|---|---|---|
| K884436 | MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 | Harris Mfg. Co. | 1988-12-02 | 42 | 0 |
| K813327 | SEPCOR TEMPERATURE MONITOR | Separation Science Corp. | 1981-12-31 | 37 | 0 |
| K802319 | HEMOTEMP TM | Marion Laboratories, Inc. | 1980-10-10 | 17 | 0 |
| K800667 | MONITEMP BLOOD PACK TEMP. MONITOR | Liquid Crystal Products, Inc. | 1980-04-16 | 21 | 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