Cleared Traditional

K915817 - TECNOL FLUIDSHIELD INFECTION CONTROL MASK

K915817 is an FDA 510(k) clearance for TECNOL FLUIDSHIELD INFECTION CONTROL MASK, manufactured by Tecnol Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K915817 · Tecnol Medical Products, Inc. · General Hospital
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Jan 1993
Decision
394d
Days
Class 2
Risk

K915817 is an FDA 510(k) clearance for the TECNOL FLUIDSHIELD INFECTION CONTROL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tecnol Medical Products, Inc. (Fort Worth, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tecnol Medical Products, Inc. devices

FDA 510(k) Submission Details - K915817

510(k) Number K915817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1991
Decision Date January 27, 1993
Days to Decision 394 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
265d slower than avg
Panel avg: 129d · This submission: 394d
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 452
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K915817.
BARRIER LASER PLUS FACE MASK
K934194 · Johnson & Johnson Medical, Inc. · Mar 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · Johnson & Johnson Medical, Inc. · Feb 1994
BUFFALO FILTER SURGICAL MASK
K930067 · Buffalo Filter Co., Inc. · Nov 1993
TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
K920162 · Tecnol Medical Products, Inc. · Jan 1993
TECNOL INFECTION CONTROL MASK
K920203 · Tecnol Medical Products, Inc. · Oct 1992
CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
K920846 · Trinity Laboratories, Inc. · Sep 1992