Cleared Traditional

SPLASH GUARD GOGGLE (K891052) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K891052 · Dispomed, Inc. · General Hospital
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Apr 1989
Decision
44d
Days
Class 2
Risk

K891052 is an FDA 510(k) clearance for the SPLASH GUARD GOGGLE. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Dispomed, Inc. (Burbank, US). The FDA issued a Cleared decision on April 12, 1989 after a review of 44 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dispomed, Inc. devices

Submission Details

510(k) Number K891052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date April 12, 1989
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 401
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K891052.
SURGICAL APPAREL
K914832 · W.L. Gore & Associates, Inc. · Feb 1992
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
K910110 · 3M Company · Mar 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · 3M Company · May 1988