510(k) · Cleared
Cleared3M Model 1860 Health Care Particulate Respirator Type N95
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FXX Mask, Surgical
Cleared on May 1, 1996 after a 159-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 1, 1996
- Review
- 159 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK955382 3M Model 1860 Health Care Particulate Respirator Type N953M Company · 1996
- Descendant · cites it directly · 0 of its ownK964723 Racal N95 ResiratorRacal Filter Technologies, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK964722 Delta N95 RespiratorRacal Filter Technologies, Inc. · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955382 | 3M Model 1860 Health Care Particulate Respirator Type N95 | 3M Company | 1996 | — |
| +1 | K964723 | Racal N95 Resirator | Racal Filter Technologies, Inc. | 1997 | — |
| +1 | K964722 | Delta N95 Respirator | Racal Filter Technologies, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
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 FXX? 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 FXX device
- #1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | 3M Model 1812 surgical mask Named without a submission number | |
| * | — | Tecnol DMR2010 respirator Named without a submission number | |
| * | — | Lazer™ Surgical Mask Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K964723 (Racal Filter Technologies, Inc., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
Meets the CDC guidelines for TB exposure control
Has a filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator)
Minimizes wearer exposure to certain airborne particles in a size range of 0.1 to 10.0 microns, such as those generated by electrocautery, laser, and other powered medical instruments
Designed to be fluid resistant to splash and spatter of blood and body fluids and other potentially hazardous biomaterials
Provides greater than 999 Racicrial Filtration Efficiency* to exhaied wearer generated microorganisims (*as determined by the modified Greene and Vesley test meihod)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955382 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955382: 3M Model 1860 Health Care Particulate Respirator Type N95.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955382
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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