Cleared Abbreviated

K062663 - MOLDEX HEALTH CARE N95 PARTICULATE RESP...

K062663 is an FDA 510(k) clearance for MOLDEX HEALTH CARE N95 PARTICULATE RESP..., manufactured by Moldex/Metric, Inc.. The device is a Class 2 General Hospital device with product code MSH cleared through the Abbreviated 510(k) pathway after a 34-day FDA review.

K062663 · Moldex/Metric, Inc. · General Hospital
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Oct 2006
Decision
34d
Days
Class 2
Risk

K062663 is an FDA 510(k) clearance for the MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Moldex/Metric, Inc. (Culver City, US). The FDA issued a Cleared decision on October 11, 2006 after a review of 34 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Moldex/Metric, Inc. devices

FDA 510(k) Submission Details - K062663

510(k) Number K062663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2006
Decision Date October 11, 2006
Days to Decision 34 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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.