Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Oxboro Medical Intl., Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
207 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953068 | OXBORO-MEDICAL FOAM INSTRUMENT HOLDER | Oxboro Medical Intl., Inc. | 1996-01-23 | 207 | 0 |
| K952787 | FOAM INSTRUMENT GUARD | Oxboro Medical Intl., Inc. | 1995-12-28 | 192 | 0 |
| K952783 | OXBORO-MEDICAL PIN COVERS | Oxboro Medical Intl., Inc. | 1995-09-15 | 88 | 0 |
| K952784 | OXBORO-MEDICAL CAUTERY TIP CLEANER | Oxboro Medical Intl., Inc. | 1995-07-13 | 24 | 0 |
| K874813 | OMED WOUND CLOSURE STRIPS | Oxboro Medical Intl., Inc. | 1988-01-29 | 66 | 1 |
| K880028 | OMED DISPOSABLE SCALPEL | Oxboro Medical Intl., Inc. | 1988-01-29 | 24 | 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