Cleared Traditional

K831357 - BOUNDARY HEADWEAR (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K831357 · Procter & Gamble Mfg. Co. · General & Plastic Surgery device
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Jun 1983
Decision
37d
Days
Class 1
Risk

K831357 is an FDA 510(k) clearance for the BOUNDARY HEADWEAR. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 37 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 Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K831357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1983
Decision Date June 02, 1983
Days to Decision 37 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
77d faster than avg
Panel avg: 114d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYF Cap, Surgical
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.