510(k) · Cleared
ClearedHandan N95 Particulate Respirators and Surgical Mask, Models HY8510 and HY9810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handan Hengyong Protective & Clean Products Co., L · MSH Respirator, Surgical
Cleared on Apr 4, 2008 as substantially equivalent to K041855 (Aearo Co., 2004) and 1 other predicate after a 10-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Apr 4, 2008
- Review
- 10 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922507 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
- 2 generations backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
- 1 generation backK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
- This deviceK080827 Handan N95 Particulate Respirators and Surgical Mask, Models HY8510…Handan Hengyong Protective & Clean Products Co., L · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −2 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| −1 | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Co. | 2004 | — |
| 0 (this device) | K080827 | Handan N95 Particulate Respirators and Surgical Mask, Models HY8510 and HY9810 | Handan Hengyong Protective & Clean Products Co., L | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SSummary page 2…Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810 are substantially equivalent is safety and effectiveness to the predicate device. Aearo Company-- K041855 Pleated plus 1050 and 1050S Gerson Isolair Compay - k960778 APR Type N95 model 2735 for reference: FXX, 878, 4040. Class II Man… | 2004 |
| * | K960778 | Isolair Apr Type N95Summary page 2…10 & HY9810 are substantially equivalent is safety and effectiveness to the predicate device. Aearo Company-- K041855 Pleated plus 1050 and 1050S Gerson Isolair Compay - k960778 APR Type N95 model 2735 for reference: FXX, 878, 4040. Class II Manufacturer Handan Hengyong Protective & Clean… | 1996 |
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 16 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K041855.
How does its category compare?
All MSH devicesMSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 are intended for single 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080827: Handan N95 Particulate Respirators and Surgical Mask, Models HY8510 and HY9810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080827
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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