FDA product code HTR: Rasp
HTR is the FDA product code for rasp. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 9 510(k) submissions under HTR, from 7 different applicants. The average 510(k) review took 40 days (median 16). FDA has posted 2 recalls for HTR devices.
Classification
| Field | Value |
|---|---|
| Device name | Rasp |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HTR clearance
Top HTR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biodynamic Technologies, Inc. | 3 | 1987-02-13 |
| Richard'S Medical Equip., Inc. | 1 | 1981-11-20 |
| Dyonics, Inc. | 1 | 1981-09-24 |
| Amsco Co. | 1 | 1978-05-16 |
| Howmedica Corp. | 1 | 1978-01-12 |
2 more applicants have HTR clearances. See the full list in Caduvo.
Most recent HTR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870349 | Biodynamic Technologies, Inc. | BIODYNAMICS FEMORAL CANAL BRUSH #1201 | 1987-02-13 | 16 |
| K870329 | Biodynamic Technologies, Inc. | ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 | 1987-02-13 | 16 |
| K870333 | Biodynamic Technologies, Inc. | BIODYNAMICS SMALL JOINT BRUSH #1203 | 1987-02-13 | 16 |
| K813093 | Richard'S Medical Equip., Inc. | RICHARDS ACETABULAR BRUSH | 1981-11-20 | 18 |
| K812506 | Dyonics, Inc. | THE ARTHROFILE | 1981-09-24 | 23 |
Recalls for HTR devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-03.
Frequently asked questions
What is FDA product code HTR?
HTR is the FDA product code for rasp. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HTR?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTR?
Across 9 cleared submissions the average was 40 days from receipt to decision (median 16).
Which companies have the most HTR clearances?
Biodynamic Technologies, Inc. (3); Richard'S Medical Equip., Inc. (1); Dyonics, Inc. (1); Amsco Co. (1); Howmedica Corp. (1).
Have HTR devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HTR
- Run a recall and safety report across every HTR manufacturer
- Watch product code HTR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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