510(k) · Cleared
ClearedSpectrashield 9500 Surgical N95 Respirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexera Medical, Inc. · ONT N95 Respirator With Antimicrobial/Antiviral Agent
Cleared on Jul 5, 2012 as substantially equivalent to K090414 (Nexera Medical, Inc., 2011) after a 160-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Jul 5, 2012
- Review
- 160 days
- Class
- Class II
- Product code
- ONT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970835 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 4 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 3 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 2 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 1 generation backK090414 Spectrashield 9500 Surgical MaskNexera Medical, Inc. · 2011
- This deviceK120244 Spectrashield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK150729 SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150729SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −4 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −3 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −2 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −1 | K090414 | Spectrashield 9500 Surgical Mask | Nexera Medical, Inc. | 2011 | — |
| 0 (this device) | K120244 | Spectrashield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2012 | — |
| +1 | K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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 ONT? 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K090414 | Spectrashield 9500 Surgical MaskSummary page 1…ication Name: Surgical mask Classification Product Code: ONT Regulation Number: 21ICFR 878.4040 Predicate K090414 SpectraShield 9500 Surgical N95 Respirator Device Information: Device The SpectraShield model 9500 Surgical Mask is… | 2011 |
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 |
|---|---|---|---|
| K150729 | SpectraShield 9500 Surgical N95 Respirator | 2015 | 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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K150729 (Nexera Medical, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ONT devicesONT N95 Respirator With Antimicrobial/Antiviral Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ONT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · ONT
Too few ONT 510(k)s in any year since 2007 to give a median.
Recalls per year · ONT
No recall names ONT since 2007.
Adverse event reports per year · ONT
1in 2020
MAUDE reports naming product code ONT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer…
Read the full statement (172 words)
The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical N95 respirator is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120244 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120244: Spectrashield 9500 Surgical N95 Respirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120244
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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