Cleared Traditional

K955513 - SURGICAL MASK (NON-STERILE)

K955513 is an FDA 510(k) clearance for SURGICAL MASK (NON-STERILE), manufactured by United Medical Ent., Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K955513 · United Medical Ent., Inc. · General Hospital
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Apr 1996
Decision
140d
Days
Class 2
Risk

K955513 is an FDA 510(k) clearance for the SURGICAL MASK (NON-STERILE). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by United Medical Ent., Inc. (Grovetown, US). The FDA issued a Cleared decision on April 22, 1996 after a review of 140 days - within the typical 510(k) review window.

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: 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.

View all United Medical Ent., Inc. devices

FDA 510(k) Submission Details - K955513

510(k) Number K955513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date April 22, 1996
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 495
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