Cleared Traditional

N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 (K072067) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 K072067.
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
K233022 · Owens & Minor (O&M) Halyard, Inc. · Jan 2024
Master-Frank N95 Particulate Respirator
K172963 · Master & Frank Enterprise Co., Ltd. · Apr 2018
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
K121069 · 3M Company · Feb 2013
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
K063023 · 3M Company · Feb 2007