Cleared Traditional

K865023 - COVER, SHOE OPERATING ROOM

K865023 is an FDA 510(k) clearance for COVER, manufactured by Ulti-Med Intl., Inc.. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K865023 · Ulti-Med Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
20d
Days
Class 1
Risk

K865023 is an FDA 510(k) clearance for the COVER, SHOE OPERATING ROOM. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Ulti-Med Intl., Inc. (Schaumburg, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 20 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 Ulti-Med Intl., Inc. devices

FDA 510(k) Submission Details - K865023

510(k) Number K865023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date January 12, 1987
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 21
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K865023.
TECNOL GAITERS PRODUCT NUMBER 47725-010
K893702 · Tecnol New Jersey Wound Care, Inc. · Jun 1989
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010
K882128 · Tecnol New Jersey Wound Care, Inc. · Jun 1988
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
OVERSHOES (SURCHAUSSURES
K851554 · Roseburg SA · Apr 1985