510(k) · Cleared
ClearedMINT MONO Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Biomed Corporation · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Sep 18, 2026 as substantially equivalent to K181582 (Demetech Corporation, 2018) after a 263-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Sep 18, 2026
- Review
- 263 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013274 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK013274 Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical · 2001 · Recalled
- 2 generations backK082097 Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureDemetech Corp. · 2010
- 1 generation backK181582 DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation · 2018
- This deviceK254238 MINT MONO SuturesHans Biomed Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013274 | Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile | Cp Medical | 2001 | 3 |
| −2 | K082097 | Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture | Demetech Corp. | 2010 | — |
| −1 | K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | 2018 | — |
| 0 (this device) | K254238 | MINT MONO Sutures | Hans Biomed Corporation | 2026 | — |
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 NEW? 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 NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 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 |
|---|---|---|---|
| * | K181582 | DemeTECH DemeDIOX absorbable surgical sutureSummary page 5…Plastic Surgery 5. Legally Marketed Predicate Device Device name: DemeDIOX Absorbable Surgical Suture 510(k) number: K181582 Manufacturer: Demetech Corporation Page 1 of 4 === Pa… | 2018 |
| † | K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043… | 2023 |
| † | K173779 | Rexmono, Pdrex | 2018 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K181582.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, 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 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
MINT MONO Sutures are comprised of PDO and are indicated for use in soft tissue approximation where use of an absorbable suture is appropriate.
The suture is not intended for lifting or filling aesthetic uses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254238: MINT MONO Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254238
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026