MNK
6 FDA 510(k) clearances · Product code
173 daysmedian time to decision
261 days90th percentile
6clearances measured
FDA profile
- Official device name
- Endoscopic Bite Block
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.
- Adverse events (MAUDE)
- 2019: 16 · 2020: 13 · 2021: 15 · 2024: 21 · 2025: 39 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OXYGEN MOUTHGUARD (K944049) | Endovations, Inc. | 1994-10-11 |
| ENCOMPAS COMFORT BLOCK # 0B-10 (K933537) | Encompas Unlimited, Inc. | 1994-04-08 |
| OXY-BLOC (K931044) | Gi Supply | 1993-10-04 |
| OVERTUBE FOR ENDSCOPIC LIGATOR (K924764) | Superior Healthcare Group, Inc. | 1993-03-15 |
| OXYGUARD (K914978) | Stantex Pty , Ltd. | 1992-01-10 |
| BITE BLOCK (K896691) | Endoscopix | 1990-02-12 |
Track MNK automatically
Every clearance here is in the API, with alerts when new ones post.