Cleared Traditional

K072067 - N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028

K072067 is an FDA 510(k) clearance for N95 SURGICAL RESPIRATOR, manufactured by Shuenn Bao Shing Corporation. The device is a Class 2 General Hospital device with product code MSH cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K072067 · Shuenn Bao Shing Corporation · General Hospital
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Jan 2008
Decision
165d
Days
Class 2
Risk

K072067 is an FDA 510(k) clearance for the N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Shuenn Bao Shing Corporation (Hsin Chu City, TW). The FDA issued a Cleared decision on January 8, 2008 after a review of 165 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.

View all Shuenn Bao Shing Corporation devices

FDA 510(k) Submission Details - K072067

510(k) Number K072067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2007
Decision Date January 08, 2008
Days to Decision 165 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 129d · This submission: 165d
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 7
Devices cleared under the same product code (MSH) and FDA review panel - the closest regulatory comparables to K072067.
Master-Frank N95 Particulate Respirator
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K063023 · 3M Company · Feb 2007
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
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PCM 2000
K970448 · Tecnol Medical Products, Inc. · Apr 1997