Cleared Traditional

K911891 - FLUIDSHIELD(TM) CONE CLASSIC(TM) II SUR...

K911891 is an FDA 510(k) clearance for FLUIDSHIELD(TM) CONE CLASSIC(TM) II SUR..., 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 74-day FDA review.

K911891 · Tecnol New Jersey Wound Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
74d
Days
Class 2
Risk

K911891 is an FDA 510(k) clearance for the FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK. 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 12, 1991 after a review of 74 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 - K911891

510(k) Number K911891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date July 12, 1991
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 K911891.
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 CONE CLASSIC II SURG MASK W/SPLASH VIS
K911907 · 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