Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Respire Medical Holding · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017-05-26 | 80 | 0 |
| K152292 | Respire Blue Series-EF | Respire Medical Holding | 2015-12-07 | 116 | 0 |
| K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | 2015-08-27 | 174 | 3 |
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