510(k) · Cleared
Cleared3M Health Care Particulate Respirator and Surgical Mask, Model 1870
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · MSH Respirator, Surgical
Cleared on Feb 23, 2007 after a 144-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Feb 23, 2007
- Review
- 144 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK063023 3M Health Care Particulate Respirator and Surgical Mask, Model 18703M Company · 2007
- Descendant · cites it directly · 3 of its ownK121069 3M Vflex Health Care Particulate Respirator and Surgical Mask3M Company · 2013
- Descendant · cites it directly · 3 of its ownK093179 Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010
- Descendant · 2 generations on · 2 of its ownK172500 Technoweb Surgical MaskYts Global, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK202139 Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK122702 Biofriend Biomask N95 Surgical RespiratorFilligent Limited · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K1210693M Vflex Health Care Particulate Respirator and Surgical Mask3M Company · 2013 · cites it directly3descendants
- K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010 · cites it directly3descendants
- K172500Technoweb Surgical MaskYts Global, Inc. · 2018 · 2 generations on2descendants
- K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020 · 2 generations on1descendant
- K122702Biofriend Biomask N95 Surgical RespiratorFilligent Limited · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063023 | 3M Health Care Particulate Respirator and Surgical Mask, Model 1870 | 3M Company | 2007 | — |
| +1 | K121069 | 3M Vflex Health Care Particulate Respirator and Surgical Mask | 3M Company | 2013 | — |
| +1 | K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) | H&H Research Company | 2010 | — |
| +2 | K172500 | Technoweb Surgical Mask | Yts Global, Inc. | 2018 | — |
| +2 | K202139 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020 | — |
| +1 | K122702 | Biofriend Biomask N95 Surgical Respirator | Filligent Limited | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121069 | 3M Vflex Health Care Particulate Respirator and Surgical Mask | 2013 | 3 |
| K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) | 2010 | 3 |
| K122702 | Biofriend Biomask N95 Surgical Respirator | 2013 | 1 |
| K171116 | 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | 2017 | 0 |
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?
- Of its descendants, K121069 (3M Company, 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MSH devicesMSH 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
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?
This product meets CDC guidelines for M. tuberculosis exposure control. As a respirator, it is intended to help reduce wearer exposure to certain airborne particles including those generated by electrocautery, laser surgery, and other powered medical instruments. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063023: 3M Health Care Particulate Respirator and Surgical Mask, Model 1870.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063023
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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