Cleared Traditional

K851556 - OP-FACE MASK(MASQUE DE CHIRUGIE)

K851556 is an FDA 510(k) clearance for OP-FACE MASK(MASQUE DE CHIRUGIE), manufactured by Roseburg SA. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K851556 · Roseburg SA · General Hospital
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Apr 1985
Decision
14d
Days
Class 2
Risk

K851556 is an FDA 510(k) clearance for the OP-FACE MASK(MASQUE DE CHIRUGIE). Classified as Mask, Surgical (product code FXX), Class II - Special 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 Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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 - K851556

510(k) Number K851556 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 Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K851556.
TECNOL FLUID SHIELD SURGICAL MASK
K874608 · Tecnol New Jersey Wound Care, Inc. · Dec 1987
TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE
K873785 · Tecnol New Jersey Wound Care, Inc. · Nov 1987
TECNOL CLASSIC CONE MASK
K870056 · Tecnol New Jersey Wound Care, Inc. · Feb 1987
PERITONEAL DIALYSIS COIL CATHETER
K850247 · Sil-Med Corp. · Feb 1985
HIGH FILTRATION ISO-MASK
K831148 · Tecnol New Jersey Wound Care, Inc. · Jul 1984
TWO-PLY PAPER FACE FACE MASK
K832281 · Abco Dealers, Inc. · Aug 1983