Cleared Traditional

K903486 - MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493

K903486 is an FDA 510(k) clearance for MASK, manufactured by Pennsylvania Association For the Blind. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K903486 · Pennsylvania Association For the Blind · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
84d
Days
Class 2
Risk

K903486 is an FDA 510(k) clearance for the MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Pennsylvania Association For the Blind (Washington, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pennsylvania Association For the Blind devices

FDA 510(k) Submission Details - K903486

510(k) Number K903486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 23, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 520
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K903486.
ANTI-FOR SURGICAL FACE MASK
K905865 · Anago, Inc. · Mar 1991
SURGICAL FACE MASK
K905749 · Anago, Inc. · Mar 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991
THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK
K902546 · Anago, Inc. · Sep 1990
THE PROTECTOR II, LASER SURGICAL MASK
K902547 · Anago, Inc. · Sep 1990
TECNOL LAZER(TM) SURGICAL MASK
K896193 · Tecnol New Jersey Wound Care, Inc. · Feb 1990