510(k) · Cleared
ClearedTechnoweb Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yts Global, Inc. · FXX Mask, Surgical
Cleared on Mar 1, 2018 as substantially equivalent to K121069 (3M Company, 2013) after a 195-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Mar 1, 2018
- Review
- 195 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063023 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK063023 3M Health Care Particulate Respirator and Surgical Mask, Model 18703M Company · 2007
- 1 generation backK121069 3M Vflex Health Care Particulate Respirator and Surgical Mask3M Company · 2013
- This deviceK172500 Technoweb Surgical MaskYts Global, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK243342 KP Protective Face MaskKp Trading Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK223270 POSE™ Health Care Surgical MaskAmerica'S Supply Chains · 2022
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 |
|---|---|---|---|---|---|
| −2 | K063023 | 3M Health Care Particulate Respirator and Surgical Mask, Model 1870 | 3M Company | 2007 | — |
| −1 | K121069 | 3M Vflex Health Care Particulate Respirator and Surgical Mask | 3M Company | 2013 | — |
| 0 (this device) | K172500 | Technoweb Surgical Mask | Yts Global, Inc. | 2018 | — |
| +1 | K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 2025 | — |
| +1 | K223270 | POSE™ Health Care Surgical Mask | America'S Supply Chains | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K121069 | 3M Vflex Health Care Particulate Respirator and Surgical MaskSummary page 4…SH Device Class II per 21 CFR 878.4040 Classification Predicate Device = 3M VFlexTM Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S cleared under K121069 Table — Substantial Equivalence Comparison. Seos S S e | Substantial Proprietary Finetex ,E-:nl,‘?.‘,\,mc't : 3M… | 2013 |
What descends from it? (2)
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)
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 11 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243342 (Kp Trading Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Technoweb Sugical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from 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/K172500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172500: Technoweb Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172500
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