FDA product code HWN: Instrument, Compression
HWN is the FDA product code for instrument, compression. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under HWN, from 4 different applicants. The average 510(k) review took 48 days (median 24). FDA has posted 9 recalls for HWN devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Compression |
| 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 HWN clearance
Top HWN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Ortho-Technology, Inc. | 1 | 1986-03-03 |
| Synthes (Usa) | 1 | 1979-12-05 |
| Richard Wolf Medical Instruments Corp. | 1 | 1977-03-07 |
| Richard'S Medical Equip., Inc. | 1 | 1976-11-23 |
Most recent HWN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854241 | Advanced Ortho-Technology, Inc. | AOT EXTERNAL COMPRESS DEVICE | 1986-03-03 | 133 |
| K792253 | Synthes (Usa) | ARICULATED TENSION DEVICE SYNTHES TEN | 1979-12-05 | 28 |
| K770349 | Richard Wolf Medical Instruments Corp. | RIGID TEACHING ATTACHMENT | 1977-03-07 | 13 |
| K760970 | Richard'S Medical Equip., Inc. | FLORIO CPC BAND | 1976-11-23 | 19 |
Recalls for HWN devices
9 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-02-16.
Frequently asked questions
What is FDA product code HWN?
HWN is the FDA product code for instrument, compression. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWN?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWN?
Across 4 cleared submissions the average was 48 days from receipt to decision (median 24).
Which companies have the most HWN clearances?
Advanced Ortho-Technology, Inc. (1); Synthes (Usa) (1); Richard Wolf Medical Instruments Corp. (1); Richard'S Medical Equip., Inc. (1).
Have HWN devices been recalled?
Yes: 9 product recalls across 1 recall events; the most recent began 2010-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HWN
- Run a recall and safety report across every HWN manufacturer
- Watch product code HWN 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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