FDA product code FMP: Protector, Skin Pressure
FMP is the FDA product code for protector, skin pressure. It is a Class I device, regulated under 21 CFR 880.6450 and reviewed by the General Hospital panel. FDA has cleared 23 510(k) submissions under FMP, from 21 different applicants. The average 510(k) review took 43 days (median 30). FDA has posted 4 recalls for FMP devices.
Classification
| Field | Value |
|---|---|
| Device name | Protector, Skin Pressure |
| Device class | Class I |
| Regulation | 21 CFR 880.6450 |
| 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 FMP clearance
Top FMP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 2 | 1981-09-11 |
| Fibre Formations, Inc. | 2 | 1979-09-24 |
| Invictus Medical, Inc. | 1 | 2015-05-01 |
| Richard Hamer Assoc., Inc. | 1 | 1995-07-31 |
| Medsurg Industries, Inc. | 1 | 1994-03-28 |
16 more applicants have FMP clearances. See the full list in Caduvo.
Most recent FMP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150243 | Invictus Medical, Inc. | Invictus Medical GelShield | 2015-05-01 | 88 |
| K951325 | Richard Hamer Assoc., Inc. | COMFEEL PLUS PRESSURE RELIEF DRESSING | 1995-07-31 | 130 |
| K934731 | Medsurg Industries, Inc. | MEDSURG STERILE IMAGING PRODUCTS | 1994-03-28 | 180 |
| K820584 | Abco Dealers, Inc. | DECUBICARE PADS & ACCESSORIES | 1982-03-25 | 21 |
| K812344 | Fred Sammons, Inc. | HEEL OR ELBOW PROTECTOR | 1981-09-11 | 24 |
Recalls for FMP devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-06-09.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code FMP?
FMP is the FDA product code for protector, skin pressure. It is a Class I device, regulated under 21 CFR 880.6450 and reviewed by the General Hospital panel.
What device class is FMP?
Class I, regulation 21 CFR 880.6450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FMP?
Across 23 cleared submissions the average was 43 days from receipt to decision (median 30).
Which companies have the most FMP clearances?
Fred Sammons, Inc. (2); Fibre Formations, Inc. (2); Invictus Medical, Inc. (1); Richard Hamer Assoc., Inc. (1); Medsurg Industries, Inc. (1).
Have FMP devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2020-06-09.
Next steps
- Run an FDA pathway report with predicate devices for product code FMP
- Run a recall and safety report across every FMP manufacturer
- Watch product code FMP 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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