Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FLA · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140623 | NXSTAGE EXPRESS FLUID WARMER | Nxstage Medical, Inc. | 2014-06-16 | 97 | 0 |
| K842302 | FLUID WARMER | Organon Teknika Corp. | 1984-08-27 | 77 | 0 |
| K810021 | FLO-TEMP | Laminar Flow Industries | 1981-01-23 | 18 | 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