Cleared Abbreviated

K063023 - 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870

K063023 is an FDA 510(k) clearance for 3M HEALTH CARE PARTICULATE RESPIRATOR A..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code MSH cleared through the Abbreviated 510(k) pathway after a 144-day FDA review.

K063023 · 3M Company · General Hospital
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Feb 2007
Decision
144d
Days
Class 2
Risk

K063023 is an FDA 510(k) clearance for the 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 144 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 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 3M Company devices

FDA 510(k) Submission Details - K063023

510(k) Number K063023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date February 23, 2007
Days to Decision 144 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 129d · This submission: 144d
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 11
Devices cleared under the same product code (MSH) and FDA review panel - the closest regulatory comparables to K063023.
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
K160271 · San-M Package Co., Ltd. · Jul 2016
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
K141876 · Pasture Pharma Pte, Ltd. · Oct 2015
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
K121069 · 3M Company · Feb 2013
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
K041855 · Aearo Co. · Nov 2004
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
K042267 · Inovel, LLC · Sep 2004
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
K974068 · Tecnol Medical Products, Inc. · Dec 1997