Cleared Traditional

K934731 - MEDSURG STERILE IMAGING PRODUCTS

K934731 is an FDA 510(k) clearance for MEDSURG STERILE IMAGING PRODUCTS, manufactured by Medsurg Industries, Inc.. The device is a Class 1 General Hospital device with product code FMP cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K934731 · Medsurg Industries, Inc. · General Hospital
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Mar 1994
Decision
180d
Days
Class 1
Risk

K934731 is an FDA 510(k) clearance for the MEDSURG STERILE IMAGING PRODUCTS. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 180 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6450 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K934731

510(k) Number K934731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date March 28, 1994
Days to Decision 180 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 129d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

FMP Device Classification - Class 1, General Controls

Product Code FMP Protector, Skin Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6450
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 - FMP Protector, Skin Pressure

All 9
Devices cleared under the same product code (FMP) and FDA review panel - the closest regulatory comparables to K934731.
Invictus Medical GelShield
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SCANLAN VASCU-STATT
K802829 · Scanlan Intl., Inc. · Jan 1981
SPAN AIDS KIT
K792297 · American Hospital Supply Corp. · Dec 1979
K934731 · MEDSURG STERILE IMAGING PRODUCTS
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