Cleared Traditional

K851558 - SURGICAL CAP CALOT

K851558 is an FDA 510(k) clearance for SURGICAL CAP CALOT, manufactured by Roseburg SA. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K851558 · Roseburg SA · General & Plastic Surgery device
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Apr 1985
Decision
14d
Days
Class 1
Risk

K851558 is an FDA 510(k) clearance for the SURGICAL CAP CALOT. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on April 30, 1985 after a review of 14 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 Roseburg SA devices

FDA 510(k) Submission Details - K851558

510(k) Number K851558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date April 30, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
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 10
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K851558.
KIMBERLY-CLARK FULL COVERAGE HOOD
K875261 · Kimberly-Clark Corp. · Jan 1988
TECNOL SURGEON'S CAP
K873830 · Tecnol New Jersey Wound Care, Inc. · Oct 1987
BOUFFANT-STYLE SURGICAL CAP
K863359 · Kimberly-Clark Corp. · Sep 1986
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