Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Caradyne, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM | Caradyne, Ltd. | 2004-06-30 | 89 | 2 |
| K023565 | OXICHECK | Caradyne, Ltd. | 2003-03-28 | 156 | 0 |
| K000959 | CRITERION 60 OR PM 60 | Caradyne, Ltd. | 2000-06-22 | 90 | 0 |
| K992101 | CRITERION 40 OR PM 40 | Caradyne, Ltd. | 2000-01-06 | 198 | 0 |
| K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 | Caradyne, Ltd. | 1999-03-09 | 252 | 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