Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KZL — 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) |
|---|---|---|---|---|---|
| K813489 | ROCKING/CIRCULATING CYTO-THERM II 3570 | Cryosan, Inc. | 1982-03-04 | 93 | 0 |
| K812311 | CIRCULATING CYTO-THERMS | Cryosan, Inc. | 1981-09-16 | 30 | 0 |
| K800699 | FLO TEM (FLUID WARNER) | Chroma Products, Inc. | 1980-05-08 | 41 | 0 |
| K790936 | MODEL 114 TREONIC H150 HAEMOHEATER | Vickers America Medical Corp. | 1979-09-04 | 109 | 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