Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MNK · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
173 daysmedian FDA review time
261 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944049 | OXYGEN MOUTHGUARD | Endovations, Inc. | 1994-10-11 | 54 | 0 |
| K933537 | ENCOMPAS COMFORT BLOCK # 0B-10 | Encompas Unlimited, Inc. | 1994-04-08 | 261 | 0 |
| K931044 | OXY-BLOC | Gi Supply | 1993-10-04 | 217 | 0 |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | Superior Healthcare Group, Inc. | 1993-03-15 | 173 | 0 |
| K914978 | OXYGUARD | Stantex Pty , Ltd. | 1992-01-10 | 65 | 0 |
| K896691 | BITE BLOCK | Endoscopix | 1990-02-12 | 76 | 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