510(k) · Cleared
ClearedMINT
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 Jun 12, 2013 as substantially equivalent to K080985 (Surgical Specialties Corp, 2008) and 1 other predicate after a 138-day review. Its family tree reaches back 9 generations to 2002. 5 later devices descend from it.
- Decided
- Jun 12, 2013
- Review
- 138 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K014153 (2002). 18 ancestors in all, the oldest K915489 (1992). 5 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 5 generations between
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK130191 MINTHans Biomed Corporation · 2013
- Descendant · cites it directly · 1 of its ownK160761 DW-1CDongwon Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK190437 Delta 3300Netech Corporation · 2019
- Descendant · cites it directly · 0 of its ownK162366 Omega VLOv World Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK160705 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK143413 J+PRAS YOUNG'S ThreadY. Jacobs Medical, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 8 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 7 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 6 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 5 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 4 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK130191 MINTHans Biomed Corporation · 2013
Most influential descendants
Showing 5 of 5 · See all- K160761DW-1CDongwon Medical Co., Ltd. · 2016 · cites it directly1descendant
- K190437Delta 3300Netech Corporation · 2019 · 2 generations on0descendants
- K162366Omega VLOv World Co., Ltd. · 2018 · cites it directly0descendants
- K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. · 2016 · cites it directly0descendants
- K143413J+PRAS YOUNG'S ThreadY. Jacobs Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −8 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −7 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −6 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −5 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −4 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −3 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| −2 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
| −1 | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | 2008 | — |
| 0 (this device) | K130191 | MINT | Hans Biomed Corporation | 2013 | — |
| +1 | K160761 | DW-1C | Dongwon Medical Co., Ltd. | 2016 | — |
| +2 | K190437 | Delta 3300 | Netech Corporation | 2019 | — |
| +1 | K162366 | Omega VL | Ov World Co., Ltd. | 2018 | — |
| +1 | K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, | Y. Jacobs Medical, Inc. | 2016 | — |
| +1 | K143413 | J+PRAS YOUNG'S Thread | Y. Jacobs Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Summary page 2…here use of absorbable sutures is appropriate. Predicate device ] e Quill™ Self-Retaining System (SRS) comprised of PDO(Polydioxanone), Angiotech (Quill Medical, Inc) (K080985) ® Quill™ Synthetic Absorbable Barbed Suture, Angiotech (Quill Medical, Inc) (K042075) Safety and performance Testing was perfo… | 2008 |
| * | K042075 | Quill Synthetic Absorbable Barbed SutureSummary page 2…ning System (SRS) comprised of PDO(Polydioxanone), Angiotech (Quill Medical, Inc) (K080985) ® Quill™ Synthetic Absorbable Barbed Suture, Angiotech (Quill Medical, Inc) (K042075) Safety and performance Testing was performed per FDA'’s Class 1 Special Controls Guidance Document: Surgical Sutures, includin… | 2004 |
What descends from it? (5)
4 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 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K160761 (Dongwon Medical Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K080985.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of an
absorbable suture is appropriate.
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/K130191 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130191: MINT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130191
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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