Cleared Traditional

K914412 - MASK, SURGICAL, DISPOSABLE

K914412 is an FDA 510(k) clearance for MASK, manufactured by Industries 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 79-day FDA review.

K914412 · Industries For the Blind · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
79d
Days
Class 2
Risk

K914412 is an FDA 510(k) clearance for the MASK, SURGICAL, DISPOSABLE. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Industries For the Blind (Greensboro, US). The FDA issued a Cleared decision on December 19, 1991 after a review of 79 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 Industries For the Blind devices

FDA 510(k) Submission Details - K914412

510(k) Number K914412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date December 19, 1991
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 K914412.
TECNOL INFECTION CONTROL MASK
K920203 · Tecnol Medical Products, Inc. · Oct 1992
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
MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
K913043 · Tecnol New Jersey Wound Care, Inc. · Aug 1991
FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
K911891 · Tecnol New Jersey Wound Care, Inc. · Jul 1991