Cleared Abbreviated

K061859 - INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS

K061859 is an FDA 510(k) clearance for INOVEL HEALTH CARE N95 PARTICULATE RESP..., manufactured by Inovel, LLC. The device is a Class 2 General Hospital device with product code MSH cleared through the Abbreviated 510(k) pathway after a 12-day FDA review.

K061859 · Inovel, LLC · General Hospital
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Jul 2006
Decision
12d
Days
Class 2
Risk

K061859 is an FDA 510(k) clearance for the INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Inovel, LLC (Culver City, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 12 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 Inovel, LLC devices

FDA 510(k) Submission Details - K061859

510(k) Number K061859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2006
Decision Date July 12, 2006
Days to Decision 12 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
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.

Regulatory Consultant

Intertek Testing Services
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MSH Respirator, Surgical

All 34
Devices cleared under the same product code (MSH) and FDA review panel - the closest regulatory comparables to K061859.
RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
K061375 · Louis M. Gerson Co., Inc. · Nov 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062665 · Inovel, LLC · Oct 2006
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062663 · Moldex/Metric, Inc. · Oct 2006
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K051182 · Inovel, LLC · May 2005
GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
K050193 · Louis M. Gerson Co., Inc. · Apr 2005
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
K041855 · Aearo Co. · Nov 2004

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.