Cleared Traditional

K082258 - CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR

K082258 is an FDA 510(k) clearance for CROSSTEX ISOLITE AND ISOFLUID EARLOOP F..., manufactured by Crosstex International. 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.

K082258 · Crosstex International · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
69d
Days
Class 2
Risk

K082258 is an FDA 510(k) clearance for the CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MA.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Crosstex International (Minneapolis, US). The FDA issued a Cleared decision on October 16, 2008 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.

FDA 510(k) Submission Details - K082258

510(k) Number K082258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2008
Decision Date October 16, 2008
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
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 564
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K082258.
TIDI FACEMASK
K100800 · Tidi Products,Llc · Jun 2010
TIDI FACEMASK
K092580 · Tidi Products,Llc · Feb 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
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
K081633 · Primed Medical Products, Inc. · Aug 2008
DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE
K070407 · Dukal Corp. · Mar 2007
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
K063043 · Modern Healthcare Corp. · Mar 2007
K082258 · CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
Download PDF FDA Summary Crosstex International