510(k) · Cleared
ClearedFilbloc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Assut Europe · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on May 19, 2016 as substantially equivalent to K141776 (ETHICON, Inc., 2014) after a 442-day review. Its family tree reaches back 1 generation to 2014. 2 later devices descend from it.
- Decided
- May 19, 2016
- Review
- 442 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K141776 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK141776 Stratafix Symmetric PDS Plus Knotless Tissue Control DevicesETHICON, Inc. · 2014
- This deviceK150553 FilblocAssut Europe · 2016
- Descendant · cites it directly · 1 of its ownK242835 Suture-TOOL SystemSuturion AB · 2025
- Descendant · 2 generations on · 0 of its ownK250977 Suture-TOOL SystemSuturion AB · 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 |
|---|---|---|---|---|---|
| −1 | K141776 | Stratafix Symmetric PDS Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2014 | — |
| 0 (this device) | K150553 | Filbloc | Assut Europe | 2016 | — |
| +1 | K242835 | Suture-TOOL System | Suturion AB | 2025 | — |
| +2 | K250977 | Suture-TOOL System | Suturion AB | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K141776 | Stratafix Symmetric PDS Plus Knotless Tissue Control DevicesSummary page 4…ICATE DEVICE Name: Stratafix Symmetric PDS Plus Knotless Tissue Control Manufacturer: Ethicon, Inc. K Number: K141776 Name: PDS II Manufacturer: Ethicon, Inc. K Number: N18331 This predi… | 2014 |
| Kept off the family tree | K018331 | PDS II Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242835 | Suture-TOOL System | 2025 | 1 |
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. 2016, 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?
Filblo sutures are indicated for use in general 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/K150553 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150553: Filbloc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150553
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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