Cleared Traditional

K061864 - DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530

Also marketed or referenced as:
EAR LOOP, MODEL 1540 WITH SHIELD, MODEL 1560

K061864 is an FDA 510(k) clearance for DUKAL SURGICAL FACE MASK TIE-ON, 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 74-day FDA review.

K061864 · Dukal Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
74d
Days
Class 2
Risk

K061864 is an FDA 510(k) clearance for the DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Dukal Corp. (Hauppauge, US). The FDA issued a Cleared decision on September 15, 2006 after a review of 74 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 - K061864

510(k) Number K061864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date September 15, 2006
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 K061864.
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
PRESTIGE AMERITECH FACE MASK
K061716 · Prestige Ameritech · Aug 2006
SURGICAL FACE MASK
K060776 · Hong YA Non-Woven Products Co., Ltd. · May 2006
SURGICAL FACE MASK
K050689 · China Surgical Dressings Center Co., Ltd. · Oct 2005
K061864 · DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530
Download PDF FDA Summary Dukal Corp.