Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oem Medical Div. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
329 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924570 | OEM MULTI-VAC POWERED SUCTION PUMP | Oem Medical Div. | 1993-08-05 | 329 | 0 |
| K925893 | OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT | Oem Medical Div. | 1993-03-12 | 115 | 0 |
| K922748 | GUEDEL AIRWAY | Oem Medical Div. | 1992-07-10 | 32 | 0 |
| K811855 | SKIN SCRUB KITS | Oem Medical Div. | 1981-07-31 | 30 | 0 |
| K761297 | MOUTHPIECE SEAL | Oem Medical Div. | 1977-01-03 | 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