Cleared Traditional

K100139 - SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150

K100139 is an FDA 510(k) clearance for SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, manufactured by Safelife Corp.. The device is a Class 2 General Hospital device with product code MSH cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K100139 · Safelife Corp. · General Hospital
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May 2010
Decision
105d
Days
Class 2
Risk

K100139 is an FDA 510(k) clearance for the SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Safelife Corp. (San Diego, US). The FDA issued a Cleared decision on May 4, 2010 after a review of 105 days - within the typical 510(k) review window.

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 Safelife Corp. devices

FDA 510(k) Submission Details - K100139

510(k) Number K100139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2010
Decision Date May 04, 2010
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 K100139.
Master-Frank N95 Particulate Respirator
K172963 · Master & Frank Enterprise Co., Ltd. · Apr 2018
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
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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
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
K974068 · Tecnol Medical Products, Inc. · Dec 1997
PCM 2000
K970448 · Tecnol Medical Products, Inc. · Apr 1997