Cleared Traditional

K872935 - ANTI-INFECTION SHIELD

K872935 is an FDA 510(k) clearance for ANTI-INFECTION SHIELD, manufactured by Stackhouse Assoc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K872935 · Stackhouse Assoc. · General Hospital
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Nov 1987
Decision
105d
Days
Class 2
Risk

K872935 is an FDA 510(k) clearance for the ANTI-INFECTION SHIELD. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Stackhouse Assoc. (El Segundo, US). The FDA issued a Cleared decision on November 9, 1987 after a review of 105 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 Stackhouse Assoc. devices

FDA 510(k) Submission Details - K872935

510(k) Number K872935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date November 09, 1987
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 520
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K872935.
SAFETY SHIELD KIT
K873731 · Ballard Medical Products · Jan 1988
INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER
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TECNOL FLUID SHIELD SURGICAL MASK
K874608 · Tecnol New Jersey Wound Care, Inc. · Dec 1987
TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE
K873785 · Tecnol New Jersey Wound Care, Inc. · Nov 1987
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K851556 · Roseburg SA · Apr 1985