Cleared Traditional

K922507 - GERSON ISOLAIR APR PARTICULATE SURGICAL...

K922507 is the FDA 510(k) clearance for GERSON ISOLAIR APR PARTICULATE SURGICAL... by Louis M. Gerson Co., Inc.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K922507 · Louis M. Gerson Co., Inc. · General Hospital
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Nov 1992
Decision
173d
Days
Class 2
Risk

K922507 is an FDA 510(k) clearance for the GERSON ISOLAIR APR PARTICULATE SURGICAL MASK. 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 November 16, 1992 after a review of 173 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 Louis M. Gerson Co., Inc. devices

Submission Details

510(k) Number K922507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date November 16, 1992
Days to Decision 173 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
44d slower than avg
Panel avg: 129d · This submission: 173d
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 434
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K922507.
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 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
CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
K920846 · Trinity Laboratories, Inc. · Sep 1992
SURGICAL APPAREL
K914832 · W.L. Gore & Associates, Inc. · Feb 1992
RELIABLE CONE STYLE FACE MASK
K913558 · Anago, Inc. · Nov 1991