Cleared Traditional

K771913 - HEEL/ELBOW PROTECTOR

K771913 is the FDA 510(k) clearance for HEEL/ELBOW PROTECTOR by Alba-Waldensian, Inc.. It is a Class 1 General Hospital device (product code FMP) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K771913 · Alba-Waldensian, Inc. · General Hospital
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Nov 1977
Decision
35d
Days
Class 1
Risk

K771913 is an FDA 510(k) clearance for the HEEL/ELBOW PROTECTOR. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Alba-Waldensian, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1977 after a review of 35 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 Alba-Waldensian, Inc. devices

Submission Details

510(k) Number K771913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1977
Decision Date November 15, 1977
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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.

Regulatory Peers - FMP Protector, Skin Pressure

All 7
Devices cleared under the same product code (FMP) and FDA review panel - the closest regulatory comparables to K771913.
HEEL OR ELBOW PROTECTOR
K812344 · Fred Sammons, Inc. · Sep 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
PROTECTOR, HEEL & ELBOW
K770635 · Tecnol New Jersey Wound Care, Inc. · May 1977