Cleared Traditional

K770635 - PROTECTOR, HEEL & ELBOW (FDA 510(k) Clearance)

Class I General Hospital device.

K770635 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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May 1977
Decision
49d
Days
Class 1
Risk

K770635 is an FDA 510(k) clearance for the PROTECTOR, HEEL & ELBOW. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Hammonton, US). The FDA issued a Cleared decision on May 23, 1977 after a review of 49 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 Tecnol New Jersey Wound Care, Inc. devices

Submission Details

510(k) Number K770635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1977
Decision Date May 23, 1977
Days to Decision 49 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
79d faster than avg
Panel avg: 128d · This submission: 49d
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.