Cleared Traditional

K873731 - SAFETY SHIELD KIT

K873731 is an FDA 510(k) clearance for SAFETY SHIELD KIT, manufactured by Ballard Medical Products. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K873731 · Ballard Medical Products · General Hospital
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Jan 1988
Decision
158d
Days
Class 2
Risk

K873731 is an FDA 510(k) clearance for the SAFETY SHIELD KIT. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Ballard Medical Products (Washington, US). The FDA issued a Cleared decision on January 15, 1988 after a review of 158 days - an extended review cycle.

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 Ballard Medical Products devices

FDA 510(k) Submission Details - K873731

510(k) Number K873731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date January 15, 1988
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K873731.
GUARDALL SHIELD
K875008 · Anago, 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
TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE
K873785 · Tecnol New Jersey Wound Care, Inc. · Nov 1987
TECNOL CLASSIC CONE MASK
K870056 · Tecnol New Jersey Wound Care, Inc. · Feb 1987