510(k) · Cleared
ClearedTrulene Non-Absorbable Polypropylene Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sutures India Private Limited · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Jun 3, 2005 as substantially equivalent to K961389 (R. K. Medical L. L. C., 1996) after a 361-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 3, 2005
- Review
- 361 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961389 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961389 Polypropylene Nonabsorbable Surgical SuturesR. K. Medical L. L. C. · 1996
- This deviceK041511 Trulene Non-Absorbable Polypropylene Surgical SutureSutures India Private Limited · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961389 | Polypropylene Nonabsorbable Surgical Sutures | R. K. Medical L. L. C. | 1996 | — |
| 0 (this device) | K041511 | Trulene Non-Absorbable Polypropylene Surgical Suture | Sutures India Private Limited | 2005 | — |
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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 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 |
|---|---|---|---|
| Kept off the family tree | K000185 | FDA’s K000185 is Gore-Tex Dualmesh Plus Biomaterial (1 MM & 2MM) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K961389 | Polypropylene Nonabsorbable Surgical SuturesSummary page 1…Polypropylenc Nonabsorbable surgical suture, 510(k) Number KOO 185, C.P.Medical, Portiand, OR 97232. e Polypropylenc Nonabsorbable surgical suture, S10(k) Number K961389. R.K.Medical L..L..C. Danbury, CT 06810 Koy 1o SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K)… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
TRULON TM Non-absorbable Polypropylene Surgical Suture is indicated for use in soft tissue approximation and/or ligation including-use in cardiovascular, ophthalmic and neurological procedures.
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/K041511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041511: Trulene Non-Absorbable Polypropylene 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/K041511
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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