510(k) · Cleared
ClearedN95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
San-M Package Co., Ltd. · MSH Respirator, Surgical
Cleared on Jul 15, 2016 as substantially equivalent to K102092 (Prestige Ameritech, 2010) after a 164-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jul 15, 2016
- Review
- 164 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974068 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK974068 PFR95 Particulate Filter Respirator and Surgical Mask Regular Size…Tecnol Medical Products, Inc. · 1997 · Recalled
- 1 generation backK102092 Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular…Prestige Ameritech · 2010
- This deviceK160271 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and…San-M Package Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK172963 Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974068 | PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95… | Tecnol Medical Products, Inc. | 1997 | 1 |
| −1 | K102092 | Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model… | Prestige Ameritech | 2010 | — |
| 0 (this device) | K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | San-M Package Co., Ltd. | 2016 | — |
| +1 | K172963 | Master-Frank N95 Particulate Respirator | Master & Frank Enterprise Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K102092 | Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model RP CeriesSummary page 4…ly equivalent to the Prestige Ameritech Pro Gear N95 Particulate Filter Respirator and Surgical Mask cleared in K102092. A comparison between the proposed and predicate device is shown in Table 5-A below. Table 5-A. Co… | 2010 |
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 |
|---|---|---|---|
| K172963 | Master-Frank N95 Particulate Respirator | 2018 | 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 19 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K172963 (Master & Frank Enterprise Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MSH devicesMSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K160271: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K160271
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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