510(k) · Cleared
ClearedDemetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Demetech Corp. · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Jan 8, 2010 as substantially equivalent to K013274 (Cp Medical, 2001) after a 533-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Jan 8, 2010
- Review
- 533 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K013274 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013274 Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical · 2001 · Recalled
- This deviceK082097 Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureDemetech Corp. · 2010
- Descendant · cites it directly · 2 of its ownK181582 DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK254238 MINT MONO SuturesHans Biomed Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK251414 Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK191361 DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation · 2019
Most influential descendants
Showing 4 of 4 · See all- K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation · 2018 · cites it directly2descendants
- K254238MINT MONO SuturesHans Biomed Corporation · 2026 · 2 generations on0descendants
- K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd. · 2025 · 2 generations on0descendants
- K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013274 | Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile | Cp Medical | 2001 | 3 |
| 0 (this device) | K082097 | Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture | Demetech Corp. | 2010 | — |
| +1 | K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | 2018 | — |
| +2 | K254238 | MINT MONO Sutures | Hans Biomed Corporation | 2026 | — |
| +2 | K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025 | — |
| +1 | K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013274 | Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileSummary page 1…equivalent to these * predicate devices:I * CP Medical Mono-Dox Synthetic Polydioxanone Absorbable Suture 5 10K Number K013274, CP Medical Portland Oregon * Ethicon PDS II Synthetic Absorbable Monofilament Suture Polydioxanone Suture… | 2001 |
| Kept off the family tree | P018331 | Ethicon PDS II Synthetic Absorbable Monofilament Suture Polydioxanone Suture Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (4)
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?
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082097: Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082097
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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