FDA product code MHW: Dressing, Compression
MHW is the FDA product code for dressing, compression. It is a Class I device, regulated under 21 CFR 880.5075 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under MHW, from 2 different applicants. The average 510(k) review took 69 days (median 69). FDA has posted 5 recalls for MHW devices.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Compression |
| Device class | Class I |
| Regulation | 21 CFR 880.5075 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every MHW clearance
Top MHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sun Scientific, LLC | 1 | 2007-05-16 |
| Arch Development Group | 1 | 1991-08-12 |
Most recent MHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070457 | Sun Scientific, LLC | SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB | 2007-05-16 | 89 |
| K912765 | Arch Development Group | STASIS BUTTON PRSSURE DEVICE | 1991-08-12 | 49 |
Recalls for MHW devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-24.
Frequently asked questions
What is FDA product code MHW?
MHW is the FDA product code for dressing, compression. It is a Class I device, regulated under 21 CFR 880.5075 and reviewed by the General and Plastic Surgery panel.
What device class is MHW?
Class I, regulation 21 CFR 880.5075. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MHW?
Across 2 cleared submissions the average was 69 days from receipt to decision (median 69).
Which companies have the most MHW clearances?
Sun Scientific, LLC (1); Arch Development Group (1).
Have MHW devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2016-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MHW
- Run a recall and safety report across every MHW manufacturer
- Watch product code MHW 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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