Cleared Traditional

K925185 - ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS

K925185 is an FDA 510(k) clearance for ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/..., manufactured by Louis M. Gerson Co., Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 477-day FDA review.

K925185 · Louis M. Gerson Co., Inc. · General Hospital
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Feb 1994
Decision
477d
Days
Class 2
Risk

K925185 is an FDA 510(k) clearance for the ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Louis M. Gerson Co., Inc. (Middleboro, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 477 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Louis M. Gerson Co., Inc. devices

FDA 510(k) Submission Details - K925185

510(k) Number K925185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1992
Decision Date February 03, 1994
Days to Decision 477 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
348d slower than avg
Panel avg: 129d · This submission: 477d
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 508
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K925185.
FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
K932137 · Tecnol Medical Products, Inc. · Apr 1994
BARRIER LASER PLUS FACE MASK
K934194 · Johnson & Johnson Medical, Inc. · Mar 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · Johnson & Johnson Medical, Inc. · Feb 1994
BUFFALO FILTER SURGICAL MASK
K930067 · Buffalo Filter Co., Inc. · Nov 1993
TECNOL FLUIDSHIELD INFECTION CONTROL MASK
K915817 · Tecnol Medical Products, Inc. · Jan 1993
TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
K920162 · Tecnol Medical Products, Inc. · Jan 1993