FDA product code HTP: File
HTP is the FDA product code for file. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under HTP, from 5 different applicants. The average 510(k) review took 112 days (median 85).
Classification
| Field | Value |
|---|---|
| Device name | File |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HTP clearance
Top HTP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intermedics Orthopedics | 1 | 1994-01-26 |
| Warsaw Orthopedic, Inc. | 1 | 1987-05-27 |
| Concept, Inc. | 1 | 1986-09-02 |
| Stainless Mfg., Inc. | 1 | 1984-06-19 |
| Suncoast Medical Manufacturers, Inc. | 1 | 1984-05-09 |
Most recent HTP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931733 | Intermedics Orthopedics | INTERMEDICS ORTHOPEDICS REAMERS | 1994-01-26 | 294 |
| K870842 | Warsaw Orthopedic, Inc. | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | 1987-05-27 | 85 |
| K862659 | Concept, Inc. | CONCEPT ARTHROSCOPY RASP | 1986-09-02 | 50 |
| K841981 | Stainless Mfg., Inc. | 4MM & 5MM FILE | 1984-06-19 | 36 |
| K840492 | Suncoast Medical Manufacturers, Inc. | SUN-LITE BLUE SLIT | 1984-05-09 | 93 |
Recalls for HTP devices
openFDA lists no recalls for product code HTP.
Frequently asked questions
What is FDA product code HTP?
HTP is the FDA product code for file. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HTP?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTP?
Across 5 cleared submissions the average was 112 days from receipt to decision (median 85).
Which companies have the most HTP clearances?
Intermedics Orthopedics (1); Warsaw Orthopedic, Inc. (1); Concept, Inc. (1); Stainless Mfg., Inc. (1); Suncoast Medical Manufacturers, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HTP
- Run a recall and safety report across every HTP manufacturer
- Watch product code HTP 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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