Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Blease Medical Equipment , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
218 daysmedian FDA review time
302 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041430 | BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 | Blease Medical Equipment , Ltd. | 2004-10-07 | 132 | 0 |
| K003251 | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, | Blease Medical Equipment , Ltd. | 2001-05-23 | 218 | 3 |
| K001727 | MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MA | Blease Medical Equipment , Ltd. | 2000-08-09 | 64 | 0 |
| K982132 | BLEASE 6200 ANAESTHESIA VENTILATOR | Blease Medical Equipment , Ltd. | 1999-04-15 | 302 | 1 |
| K982137 | BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE | Blease Medical Equipment , Ltd. | 1999-04-09 | 296 | 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