Cleared Traditional

K770391 - COVER

K770391 is the FDA 510(k) clearance for COVER by Precept, Inc.. It is a Class 1 General & Plastic Surgery device (product code BTX) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770391 · Precept, Inc. · General & Plastic Surgery device
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Mar 1977
Decision
7d
Days
Class 1
Risk

K770391 is an FDA 510(k) clearance for the COVER, ARMBOARD, DISPOSABLE. Classified as Board, Arm (with Cover), Sterile (product code BTX), Class I - General Controls.

Submitted by Precept, Inc. (Walker, US). The FDA issued a Cleared decision on March 7, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3910 - 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 Precept, Inc. devices

Submission Details

510(k) Number K770391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1977
Decision Date March 07, 1977
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTX Board, Arm (with Cover), Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3910
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.