Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cairco , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
156 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K812961 | SHEFFIELD INFANT VENTILATOR MARK 4 | Cairco , Ltd. | 1982-03-26 | 156 | 0 |
| K812957 | EAST AUTOCLAVE HUMIDIFIER | Cairco , Ltd. | 1982-03-12 | 142 | 0 |
| K812959 | SPIROX A | Cairco , Ltd. | 1982-01-22 | 93 | 0 |
| K812956 | SPIROX H | Cairco , Ltd. | 1982-01-22 | 93 | 0 |
| K812958 | EAST-FREEMAN VENTILATOR MARK 2 | Cairco , Ltd. | 1982-01-07 | 78 | 0 |
| K812955 | EAST WATER UNIT MARK 3 | Cairco , Ltd. | 1981-12-29 | 69 | 0 |
| K812953 | RADCLIFFE VENTILATOR MARK 5 | Cairco , Ltd. | 1981-11-27 | 37 | 0 |
| K812960 | EAST VENTILARM PRESSURE MONITOR ALARM S. | Cairco , Ltd. | 1981-11-16 | 26 | 0 |
| K810640 | POLARISED LIGHT GRONIOMETER | Cairco , Ltd. | 1981-04-17 | 38 | 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