510(k) · Cleared
ClearedMedical Surgical Mask-Model MP002-5, MP002-6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangmen Sure&Me Medical Product Co., Ltd. · FXX Mask, Surgical
Cleared on Jan 11, 2021 as substantially equivalent to K093179 (H&H Research Company, 2010) after a 125-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- Jan 11, 2021
- Review
- 125 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K874608 (1987). 12 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 6 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 5 generations backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- 4 generations backK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
- 3 generations backK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
- 2 generations backK092580 Tidi FacemaskTidi Products,Llc · 2010
- 1 generation backK093179 Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010
- This deviceK202577 Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −6 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −5 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| −4 | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or… | Valumax Intl., Inc. | 2004 | — |
| −3 | K051291 | Non-Sterile Surgical Mask | A.R. Medicom, Inc. | 2005 | 5 |
| −2 | K092580 | Tidi Facemask | Tidi Products,Llc | 2010 | — |
| −1 | K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) | H&H Research Company | 2010 | — |
| 0 (this device) | K202577 | Medical Surgical Mask-Model MP002-5, MP002-6 | Jiangmen Sure&Me Medical Product Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 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 FXX? 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 FXX device
- #1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)Summary page 5…atory Class: II 4. Predicate Device Information Sponsor: H&H RESEARCH COMPANY Trade Name: The New Medical Mask Classification Name: Mask, Surgical 510(K) Number: K093179 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II 5. Device Description… | 2010 |
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 34 years and passes through 8 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K093179.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
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/K202577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202577: Medical Surgical Mask-Model MP002-5, MP002-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202577
Report an extraction error
Are you the manufacturer?
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