HTR
9 FDA 510(k) clearances · Product code
16 daysmedian time to decision
220 days90th percentile
9clearances measured
FDA profile
- Official device name
- Rasp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2016: 39 · 2017: 27 · 2018: 14 · 2019: 13 · 2022: 15 · 2026: 13
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 |
|---|---|---|
| BIODYNAMICS FEMORAL CANAL BRUSH #1201 (K870349) | Biodynamic Technologies, Inc. | 1987-02-13 |
| BIODYNAMICS SMALL JOINT BRUSH #1203 (K870333) | Biodynamic Technologies, Inc. | 1987-02-13 |
| ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (K870329) | Biodynamic Technologies, Inc. | 1987-02-13 |
| RICHARDS ACETABULAR BRUSH (K813093) | Richard'S Medical Equip., Inc. | 1981-11-20 |
| THE ARTHROFILE (K812506) | Dyonics, Inc. | 1981-09-24 |
| MICRO RASPS (K780771) | Amsco Co. | 1978-05-16 |
| INTERMEDULLARY BRUSH (K771016) | Howmedica Corp. | 1978-01-12 |
| RASPS FOR SCRAPING BONE (K771745) | Depuy, Inc. | 1977-09-28 |
| PROSTHESIS, TOTAL HIP-RASP (K760109) | Orthopedic Equipment Co., Inc. | 1976-07-20 |
Track HTR automatically
Every clearance here is in the API, with alerts when new ones post.