Cleared Traditional

K092580 - TIDI FACEMASK

K092580 is an FDA 510(k) clearance for TIDI FACEMASK, manufactured by Tidi Products,Llc. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K092580 · Tidi Products,Llc · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
186d
Days
Class 2
Risk

K092580 is an FDA 510(k) clearance for the TIDI FACEMASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tidi Products,Llc (Neenah, US). The FDA issued a Cleared decision on February 23, 2010 after a review of 186 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.

FDA 510(k) Submission Details - K092580

510(k) Number K092580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2009
Decision Date February 23, 2010
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
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 564
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K092580.
WELLMIEN SURGICAL MASK
K101000 · Wellmien (Suzhou) Import & Export Trading Co., Ltd. · Aug 2010
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
K093179 · H&H Research Company · Jul 2010
TIDI FACEMASK
K100800 · Tidi Products,Llc · Jun 2010
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
K092012 · Primed Medical Products, Inc. · Sep 2009
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
K082258 · Crosstex International · Oct 2008
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
K081633 · Primed Medical Products, Inc. · Aug 2008
K092580 · TIDI FACEMASK
Download PDF FDA Summary Tidi Products,Llc