Cleared Traditional

K844705 - SHOE COVERS

K844705 is an FDA 510(k) clearance for SHOE COVERS, manufactured by Medicon, Inc.. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K844705 · Medicon, Inc. · General Hospital
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Jan 1985
Decision
38d
Days
Class 1
Risk

K844705 is an FDA 510(k) clearance for the SHOE COVERS. Classified as Cover, Shoe, Operating-room (product code FXP), 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 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 Medicon, Inc. devices

FDA 510(k) Submission Details - K844705

510(k) Number K844705 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 Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
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 22
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K844705.
NONCONDUCTIVE SHOE COVER
K864026 · Kimberly-Clark Corp. · Oct 1986
DISPOSABLE SHOE COVERS AND NURSES CAPS
K862726 · Abco Dealers, Inc. · Aug 1986
OVERSHOES (SURCHAUSSURES
K851554 · Roseburg SA · Apr 1985
PHARMA-PLAST SINGLE USE OVERSHOES
K843475 · Zimmar Consulting , Ltd. · Oct 1984
MICRO-MITT
K830821 · CooperVision, Inc. · Apr 1983
NON-CONDUCTIVE SHOE COVERS
K801616 · Procter & Gamble Mfg. Co. · Aug 1980