Cleared Traditional

K875008 - GUARDALL SHIELD

K875008 is an FDA 510(k) clearance for GUARDALL SHIELD, manufactured by Anago, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K875008 · Anago, Inc. · General Hospital
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Mar 1988
Decision
98d
Days
Class 2
Risk

K875008 is an FDA 510(k) clearance for the GUARDALL SHIELD. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on March 11, 1988 after a review of 98 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 Anago, Inc. devices

FDA 510(k) Submission Details - K875008

510(k) Number K875008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date March 11, 1988
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 440
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K875008.
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · 3M Company · May 1988
TECNOL LASER SURGICAL MASK
K874894 · Tecnol New Jersey Wound Care, Inc. · Mar 1988
TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
K880757 · Tecnol New Jersey Wound Care, Inc. · Mar 1988
KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
K875194 · Welch Allyn, Inc. · Jan 1988
TECNOL FLUID SHIELD SURGICAL MASK
K874608 · Tecnol New Jersey Wound Care, Inc. · Dec 1987