Cleared Traditional

K911907 - FLUIDSHIELD CONE CLASSIC II SURG MASK W...

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 444
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