510(k) · Cleared
ClearedPro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model RP Ceries
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prestige Ameritech · MSH Respirator, Surgical
Cleared on Oct 6, 2010 as substantially equivalent to K974068 (Tecnol Medical Products, Inc., 1997) after a 71-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Oct 6, 2010
- Review
- 71 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974068 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974068 PFR95 Particulate Filter Respirator and Surgical Mask Regular Size…Tecnol Medical Products, Inc. · 1997 · Recalled
- This deviceK102092 Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular…Prestige Ameritech · 2010
- Descendant · cites it directly · 1 of its ownK160271 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and…San-M Package Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK172963 Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd. · 2018
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 |
|---|---|---|---|---|---|
| −1 | K974068 | PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95… | Tecnol Medical Products, Inc. | 1997 | 1 |
| 0 (this device) | K102092 | Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model… | Prestige Ameritech | 2010 | — |
| +1 | K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | San-M Package Co., Ltd. | 2016 | — |
| +2 | K172963 | Master-Frank N95 Particulate Respirator | Master & Frank Enterprise Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K974068 | PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate…Summary page 2…nclusion: The Prestige Ameritech N95 Particulate Filter Respirator and Surgical Mask have the same intended use and technological characteristics as the predicate device K974068. When compared with data available and/or claims made on the predicate device, demonstrate that the technological characteristics… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | 2016 | 1 |
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?
How does its category compare?
All MSH devicesMSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Prestige Ameritech N95 Respirator and Surgical Mask RP8802O is a single use non-sterile disposable device intended to be-worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102092: Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model RP Ceries.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102092
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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