Cleared Traditional

K801195 - DERMALEX OR NATRAWOOL SKIN PRESSURE PROT

K801195 is an FDA 510(k) clearance for DERMALEX OR NATRAWOOL SKIN PRESSURE PROT, manufactured by Stock Wild & Co.. The device is a Class 1 General Hospital device with product code FMP cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K801195 · Stock Wild & Co. · General Hospital
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Jun 1980
Decision
24d
Days
Class 1
Risk

K801195 is an FDA 510(k) clearance for the DERMALEX OR NATRAWOOL SKIN PRESSURE PROT. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Stock Wild & Co. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6450 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stock Wild & Co. devices

FDA 510(k) Submission Details - K801195

510(k) Number K801195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1980
Decision Date June 09, 1980
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

FMP Device Classification - Class 1, General Controls

Product Code FMP Protector, Skin Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMP Protector, Skin Pressure

All 9
Devices cleared under the same product code (FMP) and FDA review panel - the closest regulatory comparables to K801195.
DECUBICARE PADS & ACCESSORIES
K820584 · Abco Dealers, Inc. · Mar 1982
HEEL OR ELBOW PROTECTOR
K812344 · Fred Sammons, Inc. · Sep 1981
SCANLAN VASCU-STATT
K802829 · Scanlan Intl., Inc. · Jan 1981
SPAN AIDS KIT
K792297 · American Hospital Supply Corp. · Dec 1979
HEEL OR ELBOW PROTECTOR
K772419 · Fred Sammons, Inc. · Jan 1978
SPECIALIST ARM & LEG PROTECTOR
K771519 · Johnson & Johnson Professionals, Inc. · Aug 1977