Cleared Traditional

FLARE DIS. NONWOVEN HEAD COVERS (K800810) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K800810 · Flare Products, Inc. · General & Plastic Surgery device
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May 1980
Decision
40d
Days
Class 1
Risk

K800810 is an FDA 510(k) clearance for the FLARE DIS. NONWOVEN HEAD COVERS. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Flare Products, Inc. (Walker, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 40 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 Flare Products, Inc. devices

Submission Details

510(k) Number K800810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1980
Decision Date May 20, 1980
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
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.