Cleared Traditional

K070692 - DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK

K070692 is an FDA 510(k) clearance for DUKAL N95PARTICULATE RESPIRATOR/SURGICA..., manufactured by Dukal Corporation. The device is a Class 2 General Hospital device with product code MSH cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K070692 · Dukal Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
78d
Days
Class 2
Risk

K070692 is an FDA 510(k) clearance for the DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Dukal Corporation (Hauppauge, US). The FDA issued a Cleared decision on May 30, 2007 after a review of 78 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.

View all Dukal Corporation devices

FDA 510(k) Submission Details - K070692

510(k) Number K070692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2007
Decision Date May 30, 2007
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSH Device Classification - Class 2, Special Controls

Product Code MSH Respirator, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Surgical N95 Respirator Or N95 Filtering Facepiece Respirator Is Not Exempt If It Is Intended To Prevent Specific Diseases Or Infections, Or It Is Labeled Or Otherwise Represented As Filtering Surgical Smoke Or Plumes, Filtering Specific Amounts Of Viruses Or Bacteria, Reducing The Amount Of And/or Killing Viruses, Bacteria, Or Fungi, Or Affecting Allergenicity, Or It Contains coating Technologies Unrelated To Filtration (e.g., To Reduce And Or Kill Microorganisms).  surgical N95 Respirators And N95 Filtering Facepiece Respirators Are Exempt From The Premarket Notification Procedures Subject To 21 Cfr 878.9 And The Conditions For Exemption Identified In 21 Cfr 878.4040(b)(1).
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 - MSH Respirator, Surgical

All 34
Devices cleared under the same product code (MSH) and FDA review panel - the closest regulatory comparables to K070692.
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
K080827 · Handan Hengyong Protective & Clean Products Co., L · Apr 2008
N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
K072067 · Shuenn Bao Shing Corporation · Jan 2008
AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
K072359 · Aearo Company · Nov 2007
N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
K070168 · Aearo Company · Apr 2007
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
K070782 · Survivair Respirators, LLC · Apr 2007
WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
K070139 · Survivair, Inc. · Mar 2007