Cleared Traditional

K851668 - PROSTHESIS OR SURGICAL PADS

K851668 is an FDA 510(k) clearance for PROSTHESIS OR SURGICAL PADS, manufactured by Virginia Hall, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBI cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K851668 · Virginia Hall, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
42d
Days
Class 1
Risk

K851668 is an FDA 510(k) clearance for the PROSTHESIS OR SURGICAL PADS. Classified as Material, External Aesthetic Restoration, Used With Adhesive (product code GBI), Class I - General Controls.

Submitted by Virginia Hall, Inc. (Macon, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3800 - 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 Virginia Hall, Inc. devices

FDA 510(k) Submission Details - K851668

510(k) Number K851668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date June 04, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

GBI Device Classification - Class 1, General Controls

Product Code GBI Material, External Aesthetic Restoration, Used With Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3800
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 - GBI Material, External Aesthetic Restoration, Used With Adhesive

Devices cleared under the same product code (GBI) and FDA review panel - the closest regulatory comparables to K851668.
AMOENA BREAST FORMS
K864785 · Coloplast Corp. · Jan 1987
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K864786 · Coloplast Corp. · Jan 1987
AMOENA BREAST FORMS
K853822 · Coloplast Corp. · Sep 1985
SILIMED BREAST FORM
K842765 · Sil-Med Corp. · Aug 1984
CONFORMA
K841559 · Beiersdorf, Inc. · Jul 1984