510(k) · Cleared
ClearedMoldex Health Care N95 Particulate Respirators and Surgical Masks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moldex/Metric, Inc. · MSH Respirator, Surgical
Cleared on Oct 11, 2006 as substantially equivalent to K061859 (Inovel, LLC, 2006) and 1 other predicate after a 34-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Oct 11, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922507 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
- 4 generations backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
- 3 generations backK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
- 2 generations backK051182 Inovel Health Care Model N95 Particulate Respirators and Surgical…Inovel, LLC · 2005 · Recalled
- 1 generation backK061859 Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 2006
- This deviceK062663 Moldex Health Care N95 Particulate Respirators and Surgical MasksMoldex/Metric, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −4 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| −3 | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Co. | 2004 | — |
| −2 | K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | Inovel, LLC | 2005 | 1 |
| −1 | K061859 | Inovel Health Care N95 Particulate Respirators & Surgical Masks | Inovel, LLC | 2006 | — |
| 0 (this device) | K062663 | Moldex Health Care N95 Particulate Respirators and Surgical Masks | Moldex/Metric, Inc. | 2006 | — |
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 K233022 Halyard Fluidshield 3 N95 Particulate Filter…score 6.7 · 1 generation · no Class I recall
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061859 | Inovel Health Care N95 Particulate Respirators & Surgical MasksSummary page 1…asks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1511, 1512, 1513, 1517 [(510(k) K061859] and 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP [(510(k) K051182]. These products have also been tested and appro… | 2006 |
| * | K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical MasksSummary page 1…e N95 Particulate Respirators and Surgical Masks models 1511, 1512, 1513, 1517 [(510(k) K061859] and 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP [(510(k) K051182]. These products have also been tested and approved by NIOSH as N95 Respirators.… | 2005 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K061859.
How does its category compare?
All MSH devicesMSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MSH
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSH
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSH
10in 2025
MAUDE reports naming product code MSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 78 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 4 | 60 | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The various models of Moldex 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.
https://510kreport.com/device/K062663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062663: Moldex Health Care N95 Particulate Respirators and Surgical Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062663
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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