Cleared Traditional

K920203 - TECNOL INFECTION CONTROL MASK

K920203 is an FDA 510(k) clearance for TECNOL 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 263-day FDA review.

K920203 · Tecnol Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
263d
Days
Class 2
Risk

K920203 is an FDA 510(k) clearance for the TECNOL 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 October 5, 1992 after a review of 263 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K920203

510(k) Number K920203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1992
Decision Date October 05, 1992
Days to Decision 263 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
134d slower than avg
Panel avg: 129d · This submission: 263d
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 K920203.
BUFFALO FILTER SURGICAL MASK
K930067 · Buffalo Filter Co., Inc. · Nov 1993
TECNOL FLUIDSHIELD INFECTION CONTROL MASK
K915817 · Tecnol Medical Products, Inc. · Jan 1993
TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
K920162 · Tecnol Medical Products, Inc. · Jan 1993
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