Cleared Traditional

K761268 - SKIN PRESSURE PROTECTORS (FDA 510(k) Clearance)

Class I General Hospital device.

K761268 · Mark One Healthcare Products · General Hospital
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Feb 1977
Decision
62d
Days
Class 1
Risk

K761268 is an FDA 510(k) clearance for the SKIN PRESSURE PROTECTORS. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Mark One Healthcare Products (Mchenry, US). The FDA issued a Cleared decision on February 16, 1977 after a review of 62 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.

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Submission Details

510(k) Number K761268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1976
Decision Date February 16, 1977
Days to Decision 62 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
66d faster than avg
Panel avg: 128d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.