EPP
15 FDA 510(k) clearances · Product code
43 daysmedian time to decision
87 days90th percentile
15clearances measured
FDA profile
- Official device name
- Splint, Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5800
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 2000: 1 · 2001: 1 · 2004: 1 · 2006: 4 · 2007: 2 · 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Track EPP automatically
Every clearance here is in the API, with alerts when new ones post.