Cleared Abbreviated

K063013 - PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S

K063013 is an FDA 510(k) clearance for PLEATS PLUS N95 RESPIRATOR, manufactured by Aearo Company. The device is a Class 2 General Hospital device with product code MSH cleared through the Abbreviated 510(k) pathway after a 60-day FDA review.

K063013 · Aearo Company · General Hospital
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Dec 2006
Decision
60d
Days
Class 2
Risk

K063013 is an FDA 510(k) clearance for the PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Aearo Company (Southbridge, US). The FDA issued a Cleared decision on December 1, 2006 after a review of 60 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 Aearo Company devices

FDA 510(k) Submission Details - K063013

510(k) Number K063013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date December 01, 2006
Days to Decision 60 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Standards-based clearance path.

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 K063013.
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PCM 2000
K970448 · Tecnol Medical Products, Inc. · Apr 1997