Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flexicare Medical Limited. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
252 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | 2026-01-16 | 252 | 0 |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size | Flexicare Medical Limited. | 2025-05-20 | 113 | 0 |
| K201666 | SINGLE USE MANOMETER | Flexicare Medical Limited. | 2020-11-13 | 147 | 0 |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | 2020-03-23 | 250 | 0 |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, A | Flexicare Medical Limited. | 2018-12-07 | 175 | 0 |
| K163300 | ThermoShield HME Filter | Flexicare Medical Limited. | 2017-03-22 | 120 | 0 |
| K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | Flexicare Medical Limited. | 2016-07-06 | 56 | 0 |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Flexicare Medical Limited. | 2016-06-23 | 118 | 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