510(k) · Cleared
ClearedSuture-TOOL System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suturion AB · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Jan 22, 2025 as substantially equivalent to K150553 (Assut Europe, 2016) after a 125-day review. Its family tree reaches back 2 generations to 2014. 1 later device descends from it.
- Decided
- Jan 22, 2025
- Review
- 125 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K141776 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK141776 Stratafix Symmetric PDS Plus Knotless Tissue Control DevicesETHICON, Inc. · 2014
- 1 generation backK150553 FilblocAssut Europe · 2016
- This deviceK242835 Suture-TOOL SystemSuturion AB · 2025
- Descendant · cites it directly · 0 of its ownK250977 Suture-TOOL SystemSuturion AB · 2025
Most influential descendants
Showing 1 of 1 · See all- K250977Suture-TOOL SystemSuturion AB · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K141776 | Stratafix Symmetric PDS Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2014 | — |
| −1 | K150553 | Filbloc | Assut Europe | 2016 | — |
| 0 (this device) | K242835 | Suture-TOOL System | Suturion AB | 2025 | — |
| +1 | K250977 | Suture-TOOL System | Suturion AB | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K150553 | FilblocSummary page 5…40 Device Classification Class II Review Panel General & Plastic Surgery 3. PREDICATE AND REFERENCE DEVICE Predicate Device K150553 Filbloc Reference Device K180701 SafePath Suturing System 4. DESCRIPTION OF DEVICE The Suture-TOOL System is a single-u… | 2016 |
| † | K180701 | SafePath Suturing System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250977 | Suture-TOOL System | 2025 | 0 |
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 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250977 (Suturion AB, 2025) has gone furthest, with 0 descendants of its own.
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 Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242835: Suture-TOOL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242835
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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