Cleared Traditional

K911907 - FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS

K911907 is an FDA 510(k) clearance for FLUIDSHIELD CONE CLASSIC II SURG MASK W..., manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K911907 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Jul 1991
Decision
69d
Days
Class 2
Risk

K911907 is an FDA 510(k) clearance for the FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 8, 1991 after a review of 69 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K911907

510(k) Number K911907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1991
Decision Date July 08, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
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 525
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K911907.
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
BARRIER* EXTRA PROTECTION PLUS FACE MASK
K910557 · Johnson & Johnson Medical, Inc. · Apr 1991
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
K910110 · 3M Company · Mar 1991
ANTI-FOR SURGICAL FACE MASK
K905865 · Anago, Inc. · Mar 1991