Cleared Traditional

K962286 - 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD

K962286 is an FDA 510(k) clearance for 2505 FACE MASK, manufactured by Berkley Medical Resources, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K962286 · Berkley Medical Resources, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
115d
Days
Class 2
Risk

K962286 is an FDA 510(k) clearance for the 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Berkley Medical Resources, Inc. (Uniontown, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 115 days - within the typical 510(k) review window.

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 Berkley Medical Resources, Inc. devices

FDA 510(k) Submission Details - K962286

510(k) Number K962286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1996
Decision Date October 07, 1996
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 465
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K962286.
AMSEAL SURGICAL FACE MASK
K964358 · American Seal Co. · Feb 1997
DELTA N95 RESPIRATOR
K964722 · Racal Filter Technologies, Inc. · Feb 1997
RACAL N95 RESIRATOR
K964723 · Racal Filter Technologies, Inc. · Feb 1997
BODILY FLUID DISPOSAL KIT
K961217 · Transidyne General Corp. · Jul 1996
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996
BLOODBORNE PATHOGEN KIT
K953102 · Certified Safety Mfg., Inc. · Dec 1995