510(k) · Cleared
ClearedPolyester Nonabsorbable Surgical Sutures Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R. K. Medical L. L. C. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jul 29, 1996 after a 73-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 29, 1996
- Review
- 73 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK961925 Polyester Nonabsorbable Surgical Sutures UspR. K. Medical L. L. C. · 1996
- Descendant · cites it directly · 3 of its ownK041512 Nonabsorbable (Polyethylene Terephthalate) Surgical SutureSutures India Private Limited · 2005
- Descendant · 2 generations on · 2 of its ownK160623 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2016
- Descendant · 3 generations on · 1 of its ownK172149 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2017
- Descendant · 4 generations on · 0 of its ownK231183 Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K041512Nonabsorbable (Polyethylene Terephthalate) Surgical SutureSutures India Private Limited · 2005 · cites it directly3descendants
- K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2016 · 2 generations on2descendants
- K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2017 · 3 generations on1descendant
- K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961925 | Polyester Nonabsorbable Surgical Sutures Usp | R. K. Medical L. L. C. | 1996 | — |
| +1 | K041512 | Nonabsorbable (Polyethylene Terephthalate) Surgical Suture | Sutures India Private Limited | 2005 | — |
| +2 | K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2016 | — |
| +3 | K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2017 | — |
| +4 | K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 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 |
|---|---|---|---|
| * | — | Ti-cron polyester nonabsorbable surgical suture USP Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041512 | Nonabsorbable (Polyethylene Terephthalate) Surgical Suture | 2005 | 3 |
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?
- Of its descendants, K041512 (Sutures India Private Limited, 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The polyester nonabsorbable surgical sutures USP are indicated for use in general 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/K961925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961925: Polyester Nonabsorbable Surgical Sutures Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961925
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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