Cleared Traditional

K934194 - BARRIER LASER PLUS FACE MASK

K934194 is the FDA 510(k) clearance for BARRIER LASER PLUS FACE MASK by Johnson & Johnson Medical, Inc.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K934194 · Johnson & Johnson Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
214d
Days
Class 2
Risk

K934194 is an FDA 510(k) clearance for the BARRIER LASER PLUS FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 214 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K934194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date March 28, 1994
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 129d · This submission: 214d
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 433
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K934194.
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996
PENTAX FACE MASK
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3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 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