Cleared Traditional

K012602 - CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX

K012602 is an FDA 510(k) clearance for CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, manufactured by Crosstex Intl.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K012602 · Crosstex Intl. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
162d
Days
Class 2
Risk

K012602 is an FDA 510(k) clearance for the CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FAC.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Crosstex Intl. (Great Neck, US). The FDA issued a Cleared decision on January 22, 2002 after a review of 162 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 - K012602

510(k) Number K012602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date January 22, 2002
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
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 567
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K012602.
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
K021539 · Creative Contract (M) Sdn Bhd · Mar 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
K021546 · Creative Contract (M) Sdn Bhd · Mar 2003
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307
K021076 · Primeline Medical Products, Inc. · Apr 2002
PROCEDURE MASKS: PM4-301 AND PM4-304
K011789 · Primeline Medical Products, Inc. · Jun 2001
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · White Knight Healthcare, Inc. · Apr 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · White Knight Healthcare, Inc. · Apr 2001
K012602 · CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
Download PDF FDA Summary Crosstex Intl.