510(k) · Cleared
Recalled · Class II · 2023PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate Filter Respirator and Surgical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecnol Medical Products, Inc. · MSH Respirator, Surgical
Cleared on Dec 22, 1997 after a 55-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 1997
- Review
- 55 days
- Class
- Class II
- Product code
- MSH
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK974068 PFR95 Particulate Filter Respirator and Surgical Mask Regular Size…Tecnol Medical Products, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK102092 Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular…Prestige Ameritech · 2010
- Descendant · 2 generations on · 1 of its ownK160271 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and…San-M Package Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK233022 Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical…Owens & Minor (O&M) Halyard, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK172963 Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K102092Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model RP CeriesPrestige Ameritech · 2010 · cites it directly2descendants
- K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd. · 2016 · 2 generations on1descendant
- K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft…Owens & Minor (O&M) Halyard, Inc. · 2024 · cites it directly0descendants
- K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974068 | PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95… | Tecnol Medical Products, Inc. | 1997 | — |
| +1 | K102092 | Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model… | Prestige Ameritech | 2010 | — |
| +2 | K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | San-M Package Co., Ltd. | 2016 | — |
| +1 | K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with… | Owens & Minor (O&M) Halyard, Inc. | 2024 | — |
| +3 | K172963 | Master-Frank N95 Particulate Respirator | Master & Frank Enterprise Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | Gerson Isolair APR Type N95 Model 2735 Respirator and Surgical Mask Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2023 | Class II | Z-2626-2023 | Under Investigation by firm | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K102092 (Prestige Ameritech, 2010) has gone furthest, with 2 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.
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 PFR95™ Particulate Filter Respirator and Surgical Masks are intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974068: PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate Filter Respirator and Surgical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974068
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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