510(k) · Cleared
ClearedMiracu™ Polydioxanone (PDO) Suture and Needle (MONO)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Feeltech Co., Ltd. · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Oct 20, 2025 as substantially equivalent to K181582 (Demetech Corporation, 2018) and 1 other predicate after a 166-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Oct 20, 2025
- Review
- 166 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960653 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996 · Recalled
- 3 generations backK050845 Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005 · Recalled
- 2 generations backK061037 PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · Recalled
- 1 generation backK212380 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable…ETHICON, Inc. · 2022 · Recalled
- This deviceK251414 Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) | ETHICON, Inc. | 1996 | 2 |
| −3 | K050845 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2005 | 1 |
| −2 | K061037 | PDS Plus Antibacterial Suture | ETHICON, Inc. | 2006 | 9 |
| −1 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical… | ETHICON, Inc. | 2022 | 1 |
| 0 (this device) | K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K181582 | DemeTECH DemeDIOX absorbable surgical sutureSummary page 5…878.4840 Product Code(s) NEW | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181582 DemeTECH DemeDIOX absorbable surgical suture NEW K212380 PDS™ Plus Antibacterial Polydioxanone Synthetic Sterile Suture | | NEW K… | 2018 |
| * | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureSummary page 5…te Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181582 DemeTECH DemeDIOX absorbable surgical suture NEW K212380 PDS™ Plus Antibacterial Polydioxanone Synthetic Sterile Suture | | NEW K172602 Miracu NEW K173779 PDREX NEW Device Description Su… | 2022 |
| † | K172602 | Miracu | 2018 |
| † | 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 29 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- 7 of the 9 ancestors have 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. 2025, 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 Miracu™ Absorbable Polydioxanone Suture with Needle (MONO) is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location( s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
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/K251414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251414: Miracu™ Polydioxanone (PDO) Suture and Needle (MONO).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251414
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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