FDA product code FMW: Cover, Mattress (Medical Purposes)
FMW is the FDA product code for cover, mattress (medical purposes). It is a Class I device, regulated under 21 CFR 880.6190 and reviewed by the General Hospital panel. FDA has cleared 14 510(k) submissions under FMW, from 12 different applicants. The average 510(k) review took 168 days (median 138). FDA has posted 3 recalls for FMW devices.
Classification
| Field | Value |
|---|---|
| Device name | Cover, Mattress (Medical Purposes) |
| Device class | Class I |
| Regulation | 21 CFR 880.6190 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FMW clearance
Top FMW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Precision Fabrics Group, Inc. | 2 | 2016-06-20 |
| Perfect Fit Industries, Inc. | 2 | 1993-02-10 |
| Demite Limited | 1 | 2001-12-10 |
| Allergy Direct | 1 | 1999-11-08 |
| W. L. Gore & Associates, Inc. | 1 | 1994-02-25 |
7 more applicants have FMW clearances. See the full list in Caduvo.
Most recent FMW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152884 | Precision Fabrics Group, Inc. | DermaTherapy Bed Linens | 2016-06-20 | 264 |
| K061242 | Precision Fabrics Group, Inc. | DERMATHERAPY, MODEL 22216 | 2007-01-25 | 267 |
| K001003 | Demite Limited | Z-NET | 2001-12-10 | 621 |
| K992702 | Allergy Direct | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM | 1999-11-08 | 88 |
| K940327 | W. L. Gore & Associates, Inc. | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW | 1994-02-25 | 32 |
Recalls for FMW devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-08-11.
Frequently asked questions
What is FDA product code FMW?
FMW is the FDA product code for cover, mattress (medical purposes). It is a Class I device, regulated under 21 CFR 880.6190 and reviewed by the General Hospital panel.
What device class is FMW?
Class I, regulation 21 CFR 880.6190. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FMW?
Across 14 cleared submissions the average was 168 days from receipt to decision (median 138).
Which companies have the most FMW clearances?
Precision Fabrics Group, Inc. (2); Perfect Fit Industries, Inc. (2); Demite Limited (1); Allergy Direct (1); W. L. Gore & Associates, Inc. (1).
Have FMW devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2014-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code FMW
- Run a recall and safety report across every FMW manufacturer
- Watch product code FMW 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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