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 Dec 29, 2015 as substantially equivalent to K120244 (Nexera Medical, Inc., 2012) and 1 other predicate after a 284-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Dec 29, 2015
- Review
- 284 days
- Class
- Class II
- Product code
- ONT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970835 (1997). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 5 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 4 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 3 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 2 generations backK090414 Spectrashield 9500 Surgical MaskNexera Medical, Inc. · 2011
- 1 generation backK120244 Spectrashield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2012
- This deviceK150729 SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −5 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −4 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −3 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −2 | K090414 | Spectrashield 9500 Surgical Mask | Nexera Medical, Inc. | 2011 | — |
| −1 | K120244 | Spectrashield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2012 | — |
| 0 (this device) | K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K120244 | Spectrashield 9500 Surgical N95 RespiratorSummary page 4…II Classification Product Code: ONT Regulation Number: 21 CFR 878.4040 Predicate K120244 SpectraShield 9500 Surgical N95 Respirator Device K122702 BioFriendTM BioMask TM N95 Surgical Respirator Information:… | 2012 |
| * | K122702 | Biofriend Biomask N95 Surgical RespiratorSummary page 4…Code: ONT Regulation Number: 21 CFR 878.4040 Predicate K120244 SpectraShield 9500 Surgical N95 Respirator Device K122702 BioFriendTM BioMask TM N95 Surgical Respirator Information: Device The SpectraShield model 9500 Surgical Mask is a mo… | 2013 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 9 ancestors has a recall.
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. 2015, 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 Mask is a single use, disposable, surgical mask, 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, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask.…
Read the full statement (264 words)
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, 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, and inactivates
99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. 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.
In vitro tests have demonstrated 99.99% inactivation on the surface of the outer layer of the mask when tested against the
following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes: H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A /Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask 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/K150729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150729: SpectraShield 9500 Surgical N95 Respirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150729
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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