FMP
23 FDA 510(k) clearances · Product code
30 daysmedian time to decision
88 days90th percentile
23clearances measured
FDA profile
- Official device name
- Protector, Skin Pressure
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6450
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2014: 26 · 2015: 9 · 2016: 11 · 2022: 60 · 2023: 15 · 2025: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Invictus Medical GelShield (K150243) | Invictus Medical, Inc. | 2015-05-01 |
| COMFEEL PLUS PRESSURE RELIEF DRESSING (K951325) | Richard Hamer Assoc., Inc. | 1995-07-31 |
| MEDSURG STERILE IMAGING PRODUCTS (K934731) | Medsurg Industries, Inc. | 1994-03-28 |
| DECUBICARE PADS & ACCESSORIES (K820584) | Abco Dealers, Inc. | 1982-03-25 |
| HEEL OR ELBOW PROTECTOR (K812344) | Fred Sammons, Inc. | 1981-09-11 |
| SPENCO DERMAL PADS (K811184) | Spenco Medical Corp. | 1981-05-20 |
| SCANLAN VASCU-STATT (K802829) | Scanlan Intl., Inc. | 1981-01-15 |
| ARTERIAL BLOOD SAMPLING KIT (K802185) | Current Technologies, Inc. | 1980-10-10 |
| FLOTATION PAD FOR OPERATING TABLE (K801694) | Action Products, Inc. | 1980-08-27 |
| DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (K801195) | Stock Wild & Co. | 1980-06-09 |
| SPAN AIDS KIT (K792297) | American Hospital Supply Corp. | 1979-12-20 |
| HEEL/ELBOW PROTECTORS (K791709) | Fibre Formations, Inc. | 1979-09-24 |
| CONTEX (K790995) | Foam Tek, Inc. | 1979-06-11 |
| FOAM COMFORT RINGS (K781246) | Fibre Formations, Inc. | 1978-08-10 |
| ELBOW PROTECTOR (K780171) | Stat Medical Corp. | 1978-02-06 |
| HEEL OR ELBOW PROTECTOR (K772419) | Fred Sammons, Inc. | 1978-01-26 |
| PROTECT IV GARD (K772060) | Omnicon Medical Corp. | 1977-12-20 |
| HEEL/ELBOW PROTECTOR (K771913) | Alba-Waldensian, Inc. | 1977-11-15 |
| HEEL PROTECTOR (K771633) | Medical Restraints, Inc. | 1977-09-12 |
| SPECIALIST ARM & LEG PROTECTOR (K771519) | Johnson & Johnson Professionals, Inc. | 1977-08-26 |
| PROTECTOR, HEEL & ELBOW (K770635) | Tecnol New Jersey Wound Care, Inc. | 1977-05-23 |
| SKIN PRESSURE PROTECTORS (K761268) | Mark One Healthcare Products | 1977-02-16 |
| HEEL/ELBOW FLOTATION CUSHION (K760870) | Medpro, Inc. | 1976-11-01 |
Track FMP automatically
Every clearance here is in the API, with alerts when new ones post.