Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HQA · 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) |
|---|---|---|---|---|---|
| K854411 | KEELER-COMPACT CRYO SYSTEM | Keeler Instruments, Inc. | 1985-12-30 | 59 | 0 |
| K854422 | SERIES 25 SLIMLINE CRYO PROBES | Keeler Instruments, Inc. | 1985-12-30 | 56 | 0 |
| K841294 | ACU220 CRYO UNIT | Keller Instruments, Inc. | 1984-08-15 | 139 | 0 |
| K823835 | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS | Keller Instruments, Inc. | 1983-01-17 | 27 | 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