Cleared Traditional

K061375 - RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730

K061375 is an FDA 510(k) clearance for RESPIRATOR N95 PARTICULATE RESPIRATOR, manufactured by Louis M. Gerson Co., Inc.. The device is a Class 2 General Hospital device with product code MSH cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K061375 · Louis M. Gerson Co., Inc. · General Hospital
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Nov 2006
Decision
184d
Days
Class 2
Risk

K061375 is an FDA 510(k) clearance for the RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Louis M. Gerson Co., Inc. (Middleboro, US). The FDA issued a Cleared decision on November 17, 2006 after a review of 184 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 Louis M. Gerson Co., Inc. devices

FDA 510(k) Submission Details - K061375

510(k) Number K061375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2006
Decision Date November 17, 2006
Days to Decision 184 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 slower than avg
Panel avg: 129d · This submission: 184d
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 28
Devices cleared under the same product code (MSH) and FDA review panel - the closest regulatory comparables to K061375.
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K061859 · Inovel, LLC · Jul 2006