510(k) Report

510(k) · Cleared

Cleared

Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-a

K063747510(k) TraditionalCleared Jan 12, 200724-day reviewClass II21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inovel, LLC · MSH Respirator, Surgical

Cleared on Jan 12, 2007 as substantially equivalent to K062665 (Inovel, LLC, 2006) and 2 other predicates after a 24-day review. Its family tree reaches back 5 generations to 1992.

Decided
Jan 12, 2007
Review
24 days
Class
Class II
Product code
MSH
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K922507 (1992). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorK922507 · Gerson Isolair Apr Particulate Surgical Mask · Louis M. Gerson Co., Inc. · 1992K960778 · Isolair Apr Type N95 · Louis M. Gerson Co., Inc. · 1996K041855 · Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S · Aearo Co. · 2004K051182 · Inovel Health Care Model N95 Particulate Respirators and Surgical Masks · Inovel, LLC · 2005 · recalledK061859 · Inovel Health Care N95 Particulate Respirators & Surgical Masks · Inovel, LLC · 20061990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K061859 · Inovel Health Care N95 Particulate Respirators & Surgical Masks · Inovel, LLC · 2006K051182 · Inovel Health Care Model N95 Particulate Respirators and Surgical Masks · Inovel, LLC · 2005 · recalledK041855 · Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S · Aearo Co. · 2004K960778 · Isolair Apr Type N95 · Louis M. Gerson Co., Inc. · 1996K922507 · Gerson Isolair Apr Particulate Surgical Mask · Louis M. Gerson Co., Inc. · 1992−50
  1. Root · 5 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
  2. 4 generations backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
  3. 3 generations backK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
  4. 2 generations backK051182 Inovel Health Care Model N95 Particulate Respirators and Surgical…Inovel, LLC · 2005 · Recalled
  5. 1 generation backK061859 Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 2006
  6. This deviceK063747 Inovel Health Care N95 Particulate Respirators and Surgical Masks…Inovel, LLC · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K922507Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc.1992—
−4K960778Isolair Apr Type N95Louis M. Gerson Co., Inc.1996—
−3K041855Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co.2004—
−2K051182Inovel Health Care Model N95 Particulate Respirators and Surgical MasksInovel, LLC20051
−1K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC2006—
0 (this device)K063747Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models…Inovel, LLC2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K063747, 1992–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MSH device

  1. #1 K233022 Halyard Fluidshield 3 N95 Particulate Filter…score 6.7 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K062665Inovel Health Care N95 Particulate Respirators and Surgical Masks
Summary page 1
…N95 Particulate Respirators and Surgical Masks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1510 (K062665), 1511, 1512, 1513, 1517 (K061859), 3000N95-XS, 3001N95-S, 3002N957 M, 3003N95-L, 3004N95-LP, 3101 N95-S, 3102N95-M/L, and 3104N9…
Inovel, LLC2006—
*K061859Inovel Health Care N95 Particulate Respirators & Surgical Masks
Summary page 1
…rgical Masks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1510 (K062665), 1511, 1512, 1513, 1517 (K061859), 3000N95-XS, 3001N95-S, 3002N957 M, 3003N95-L, 3004N95-LP, 3101 N95-S, 3102N95-M/L, and 3104N95-LP (K051182). These products hav…
Inovel, LLC2006—
*K051182Inovel Health Care Model N95 Particulate Respirators and Surgical Masks
Summary page 1
…urgical Masks models 1510 (K062665), 1511, 1512, 1513, 1517 (K061859), 3000N95-XS, 3001N95-S, 3002N957 M, 3003N95-L, 3004N95-LP, 3101 N95-S, 3102N95-M/L, and 3104N95-LP (K051182). These products have also been tested and approved by NIOSH as N95 Respirators Ifl O WLDif…
Inovel, LLC20051

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 6 ancestors has a recall of any class.

How does its category compare?

All MSH devices

MSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MSH

1in 2024

2007: 72008: 22009: 22010: 42013: 12015: 12016: 12017: 12018: 12024: 1
2007high 7 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSH

60in 2010

2007: 78 days median2010: 60 days median
2007high 78 (2007) · low 60 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSH

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MSH

10in 2025

2010: 22015: 32017: 22018: 42020: 592021: 192022: 182023: 712024: 12025: 10
2007high 71 (2023) · low 0 (2007)2025

MAUDE reports naming product code MSH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200777800
20082—10
20092—00
201046002
20110—00
20120—00
20131—00
20140—00
20151—03
20161—00
20171—02
20181—04
20190—00
20200—059
20210—019
20220—018
20230—071
20241—01
20250—010
20260—0—

What is it indicated for?

The various models of Inovel Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Indications for use as stated in the FDA summary.

More from Inovel, LLC

5 FDA decisions under this applicant name. See the company

  • K062665Inovel Health Care N95 Particulate Respirators and Surgical MasksInovel, LLC · 2006
  • K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 2006
  • K051182Inovel Health Care Model N95 Particulate Respirators and Surgical MasksInovel, LLC · 20051 recall
  • K042267Inovel Health Care N95 Particulate Respirator and Surgical Mask, Models 3001N95-S, 3002N95-M, 3003N95-L, and…Inovel, LLC · 20041 recall

Recent decisions in MSH

The MSH category page

  • K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange…Owens & Minor (O&M) Halyard, Inc. · 2024
  • K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd. · 2018
  • K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M Healthcare · 2017
  • K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd. · 2016
  • K141876Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95…Pasture Pharma Pte, Ltd. · 2015

https://510kreport.com/device/K063747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063747: Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063747

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026