510(k) · Cleared
ClearedTrulon Non-Absorbable Polyamide Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sutures India Private Limited · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Jun 2, 2005 as substantially equivalent to K001173 (Cp Medical, 2000) and 1 other predicate after a 360-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Jun 2, 2005
- Review
- 360 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960327 (1996). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960327 Nylon Noabsorbable Surgical Sutures UspR. K. Medical L. L. C. · 1996
- This deviceK041510 Trulon Non-Absorbable Polyamide Surgical SutureSutures India Private Limited · 2005
- Descendant · cites it directly · 2 of its ownK160623 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2016
- Descendant · 2 generations on · 1 of its ownK172149 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2017
- Descendant · 3 generations on · 0 of its ownK231183 Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2016 · cites it directly2descendants
- K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2017 · 2 generations on1descendant
- K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960327 | Nylon Noabsorbable Surgical Sutures Usp | R. K. Medical L. L. C. | 1996 | — |
| 0 (this device) | K041510 | Trulon Non-Absorbable Polyamide Surgical Suture | Sutures India Private Limited | 2005 | — |
| +1 | K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2016 | — |
| +2 | K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2017 | — |
| +3 | K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 GAR? 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 GAR device
- #1 K261484 Tissue Approximation Systemscore 11.7 · 2 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 |
|---|---|---|---|
| * | K001173 | Nylon, Nonabsorbable Surgical Sutures Usp | 2000 |
| * | K960327 | Nylon Noabsorbable Surgical Sutures UspSummary page 1…Nylon Nonabsorbable Surgical Suture. 510(k) Number KOO 1173, C.P.Medical, Portland, OR 97232. * Nylon Nonabsorbable Surgical Suture, 510(k) Number K960327. R.K.Medical L.L.C, Danbury, CT 06810… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable… | 2016 | 2 |
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 GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, 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 | 0 | — | 0 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
TRULON Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041510: Trulon Non-Absorbable Polyamide 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/K041510
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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