Cleared Traditional

K851554 - OVERSHOES (SURCHAUSSURES

K851554 is an FDA 510(k) clearance for OVERSHOES (SURCHAUSSURES, manufactured by Roseburg SA. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K851554 · Roseburg SA · General Hospital
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Apr 1985
Decision
14d
Days
Class 1
Risk

K851554 is an FDA 510(k) clearance for the OVERSHOES (SURCHAUSSURES. Classified as Cover, Shoe, Operating-room (product code FXP), 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 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 - K851554

510(k) Number K851554 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.

FXP Device Classification - Class 1, General Controls

Product Code FXP Cover, Shoe, Operating-room
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 - FXP Cover, Shoe, Operating-room

All 13
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K851554.
NON-SKID SHOE COVERS
K872797 · Abco Dealers, Inc. · Aug 1987
NONCONDUCTIVE SHOE COVER
K864026 · Kimberly-Clark Corp. · Oct 1986
DISPOSABLE SHOE COVERS AND NURSES CAPS
K862726 · Abco Dealers, Inc. · Aug 1986
MICRO-MITT
K830821 · CooperVision, Inc. · Apr 1983
NON-CONDUCTIVE SHOE COVERS
K801616 · Procter & Gamble Mfg. Co. · Aug 1980
CONDUCTIVE SHOE COVERS
K801617 · Procter & Gamble Mfg. Co. · Aug 1980