Cleared Traditional

K844704 - CAPS (O.R. NURSE, SURGICAL)

K844704 is an FDA 510(k) clearance for CAPS (O.R. NURSE, manufactured by Medicon, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K844704 · Medicon, Inc. · General & Plastic Surgery device
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Jan 1985
Decision
38d
Days
Class 1
Risk

K844704 is an FDA 510(k) clearance for the CAPS (O.R. NURSE, SURGICAL). Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Medicon, Inc. (Norwalk, US). The FDA issued a Cleared decision on January 10, 1985 after a review of 38 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 Medicon, Inc. devices

FDA 510(k) Submission Details - K844704

510(k) Number K844704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1984
Decision Date January 10, 1985
Days to Decision 38 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: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

FYF Device Classification - Class 1, General Controls

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.

Regulatory Peers - FYF Cap, Surgical

All 19
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K844704.
TECNOL SURGEON'S CAP
K873830 · Tecnol New Jersey Wound Care, Inc. · Oct 1987
BOUFFANT-STYLE SURGICAL CAP
K863359 · Kimberly-Clark Corp. · Sep 1986
SURGICAL CAP CALOT
K851558 · Roseburg SA · Apr 1985
BOUNDARY HEADWEAR
K831357 · Procter & Gamble Mfg. Co. · Jun 1983
DISPOSABLE SURGERY CAPS & HOODS
K810199 · Anago, Inc. · Feb 1981
DISPOSABLE NURSES CAP
K802186 · Anago, Inc. · Sep 1980