Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oxequip Health Ind. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
70 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833496 | OXYGEN MONITOR/CONTROLLER | Oxequip Health Ind. | 1983-12-16 | 70 | 0 |
| K812624 | OXEQUIP CONDUCTIVE & NON ANES. BREATH | Oxequip Health Ind. | 1981-10-26 | 41 | 0 |
| K811987 | OXY-QUIK MARK IV OXYGEN INHALATOR | Oxequip Health Ind. | 1981-07-27 | 14 | 0 |
| K800369 | TRI PAC MOUTH PROP | Oxequip Health Ind. | 1980-02-28 | 8 | 0 |
| K792356 | OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR | Oxequip Health Ind. | 1979-12-04 | 13 | 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