De Novo · Granted
Granted3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Granted on May 8, 2007 as a new device type through De Novo after a 217-day review. 1 later device descends from it.
- Decided
- May 8, 2007
- Review
- 217 days
- Class
- Class II
- Product code
- NZJ
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN060009 3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator3M Company · 2007
- Descendant · cites it directly · 0 of its ownK093189 Actiprotect UC N95 RespiratorGlaxosmithkline Consumer Healthcare · 2010
Most influential descendants
Showing 1 of 1 · See all- K093189Actiprotect UC N95 RespiratorGlaxosmithkline Consumer Healthcare · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN060009 | 3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator | 3M Company | 2007 | — |
| +1 | K093189 | Actiprotect UC N95 Respirator | Glaxosmithkline Consumer Healthcare | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093189 | Actiprotect UC N95 Respirator | 2010 | 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, K093189 (Glaxosmithkline Consumer Healthcare, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NZJ devicesNZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NZJ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NZJ
Too few NZJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NZJ
No recall names NZJ since 2007.
Adverse event reports per year · NZJ
1in 2021
MAUDE reports naming product code NZJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN060009 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN060009: 3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN060009
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026