Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flexicare Medical, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
76 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150900 | Flexicare Heated Wire Breathing Systems | Flexicare Medical, Ltd. | 2015-05-15 | 42 | 0 |
| K140473 | DUALGUARD | Flexicare Medical, Ltd. | 2014-04-10 | 44 | 0 |
| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | Flexicare Medical, Ltd. | 2014-03-06 | 50 | 0 |
| K132619 | CLASSIC INTERMITTENT CATHETER | Flexicare Medical, Ltd. | 2013-10-11 | 51 | 0 |
| K092218 | FLEXICARE BREATHING FILTERS | Flexicare Medical, Ltd. | 2009-10-06 | 76 | 0 |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | Flexicare Medical, Ltd. | 2009-06-17 | 15 | 1 |
| K951652 | VENTIMASK MK IV | Flexicare Medical, Ltd. | 1995-04-27 | 17 | 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