Cleared Traditional

K931288 - ISOLAIR 2 FULL FACE SPLASH GUARD

K931288 is the FDA 510(k) clearance for ISOLAIR 2 FULL FACE SPLASH GUARD by Louis M. Gerson Co., Inc.. It is a Class 1 General Hospital device (product code LYU) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K931288 · Louis M. Gerson Co., Inc. · General Hospital
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Jan 1994
Decision
315d
Days
Class 1
Risk

K931288 is an FDA 510(k) clearance for the ISOLAIR 2 FULL FACE SPLASH GUARD. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Louis M. Gerson Co., Inc. (Middleboro, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Louis M. Gerson Co., Inc. devices

Submission Details

510(k) Number K931288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1993
Decision Date January 21, 1994
Days to Decision 315 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 129d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYU Accessory, Surgical Apparel

All 7
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K931288.
DEPUY DISPOSABLE FILTER/HOOD
K961791 · Depuy, Inc. · Aug 1996
FACE-IT SHIELD
K942022 · Onyx Medical Corp. · Jul 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · W.L. Gore & Associates, Inc. · Feb 1994
ULTRATUFF CUT RESISTANT GLOVE LINER
K925628 · Baxter Healthcare Corp · Jul 1993
GUARDALL SHIELD
K915415 · Anago, Inc. · Oct 1992
CUT RESISTANT GLOVE LINER
K902633 · Biomet, Inc. · Jul 1990