Cleared Traditional

K070407 - DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE

Also marketed or referenced as:
ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE

K070407 is an FDA 510(k) clearance for DUKAL SURGICAL FACE MASK TIE, manufactured by Dukal Corp.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K070407 · Dukal Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
42d
Days
Class 2
Risk

K070407 is an FDA 510(k) clearance for the DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Dukal Corp. (Hauppauge, US). The FDA issued a Cleared decision on March 26, 2007 after a review of 42 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 - K070407

510(k) Number K070407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2007
Decision Date March 26, 2007
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 K070407.
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
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
K063043 · Modern Healthcare Corp. · Mar 2007
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530
K061864 · Dukal Corp. · Sep 2006
PRESTIGE AMERITECH FACE MASK
K061716 · Prestige Ameritech · Aug 2006
K070407 · DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE
Download PDF FDA Summary Dukal Corp.