Cleared Traditional

K812105 - ANOGO DISPOSABLE SHOE COVER

K812105 is an FDA 510(k) clearance for ANOGO DISPOSABLE SHOE COVER, manufactured by Anago, Inc.. The device is a Class 1 General & Plastic Surgery device with product code BWP cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K812105 · Anago, Inc. · General & Plastic Surgery device
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Sep 1981
Decision
49d
Days
Class 1
Risk

K812105 is an FDA 510(k) clearance for the ANOGO DISPOSABLE SHOE COVER. Classified as Shoe And Shoe Cover, Conductive (product code BWP), Class I - General Controls.

Submitted by Anago, Inc. (Walker, US). The FDA issued a Cleared decision on September 11, 1981 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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 Anago, Inc. devices

FDA 510(k) Submission Details - K812105

510(k) Number K812105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1981
Decision Date September 11, 1981
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

BWP Device Classification - Class 1, General Controls

Product Code BWP Shoe And Shoe Cover, Conductive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.