Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quality IN Flow , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
546 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fl | Quality IN Flow , Ltd. | 2022-12-08 | 546 | 0 |
| K180154 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2018-04-27 | 98 | 0 |
| K171215 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-09-27 | 155 | 0 |
| K163708 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-04-20 | 112 | 0 |
| K150404 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2016-06-23 | 491 | 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