510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FMPClass I

Protector, Skin Pressure

21 CFR 880.6450 / General Hospital
FDA source (opens on fda.gov)

FMP is the FDA product code for Protector, Skin Pressure, a class I device type, regulated under 21 CFR 880.6450. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
FMP
Device name
Protector, Skin Pressure
Regulation
21 CFR 880.6450
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
23
Ingested recalls
4

Clearances, product code FMP

By decision year
23 clearances under product code FMP with a decision year between 1976 and 2015, 1977 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code FMP by decision year
YearClearances
19761
19776
19783
19793
19803
19813
19821
19941
19951
20151

Applicants with the most clearances

Product code FMP
Applicants holding the most 510(k) clearances under product code FMP
ApplicantClearances
Fibre Formations, Inc.2
Fred Sammons, Inc.2
Abco Dealers, Inc.1
Action Products, Inc.1
Alba-Waldensian, Inc.1
American Hospital Supply1
Current Technologies, Inc.1
Foam Tek, Inc.1
Invictus Medical, Inc.1
Johnson & Johnson Professionals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 362 companies shown, in name order