510(k) · Cleared
ClearedDemeTECH DemeDIOX absorbable surgical suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Demetech Corporation · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Aug 27, 2018 as substantially equivalent to K082097 (Demetech Corp., 2010) after a 73-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 27, 2018
- Review
- 73 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013274 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK013274 Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical · 2001 · Recalled
- 1 generation backK082097 Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureDemetech Corp. · 2010
- This deviceK181582 DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation · 2018
- Descendant · cites it directly · 0 of its ownK254238 MINT MONO SuturesHans Biomed Corporation · 2026
- Descendant · cites it directly · 0 of its ownK251414 Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd. · 2025
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 | K013274 | Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile | Cp Medical | 2001 | 3 |
| −1 | K082097 | Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture | Demetech Corp. | 2010 | — |
| 0 (this device) | K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | 2018 | — |
| +1 | K254238 | MINT MONO Sutures | Hans Biomed Corporation | 2026 | — |
| +1 | K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K082097 | Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureSummary page 4…Class II D. Predicate Device: The predicate is the original DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE, 510K K082097. E. Device Description: DemeDIOX Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture… | 2010 |
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 17 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K254238 (Hans Biomed Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082097.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
DemeDIOX Absorbable Surgical Suture is indicated for use in general 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/K181582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181582: DemeTECH DemeDIOX absorbable surgical suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181582
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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