Cleared Traditional

K955557 - FLUID REISISTANT EYESHIELD MASK

K955557 is an FDA 510(k) clearance for FLUID REISISTANT EYESHIELD MASK, manufactured by American Threshold Healthcare. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K955557 · American Threshold Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
142d
Days
Class 2
Risk

K955557 is an FDA 510(k) clearance for the FLUID REISISTANT EYESHIELD MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by American Threshold Healthcare (Enka, US). The FDA issued a Cleared decision on April 25, 1996 after a review of 142 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 American Threshold Healthcare devices

FDA 510(k) Submission Details - K955557

510(k) Number K955557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date April 25, 1996
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
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 446
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K955557.
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