510(k) · Cleared
ClearedArtelon Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artimplant AB · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Nov 17, 2003 as substantially equivalent to K993998 (Trading Consultants and Distributors Intl., Inc., 2000) and 3 other predicates after a 125-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Nov 17, 2003
- Review
- 125 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930586 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930586 Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutDavis & Geck, Inc. · 1993
- 1 generation backK981582 Surgilon, Dermalon, & OphthalonDavis & Geck, Inc. · 1998 · Recalled
- This deviceK032160 Artelon Surgical SutureArtimplant AB · 2003
- Descendant · cites it directly · 0 of its ownK052482 Artelon Surgical SutureArtimplant AB · 2005
Most influential descendants
Showing 1 of 1 · See all- K052482Artelon Surgical SutureArtimplant AB · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut | Davis & Geck, Inc. | 1993 | — |
| −1 | K981582 | Surgilon, Dermalon, & Ophthalon | Davis & Geck, Inc. | 1998 | 9 |
| 0 (this device) | K032160 | Artelon Surgical Suture | Artimplant AB | 2003 | — |
| +1 | K052482 | Artelon Surgical Suture | Artimplant AB | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 11.8 · 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? (4)
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 |
|---|---|---|---|
| * | K993998 | NYLONSummary page 1…GAR- Surgical, Nonabsorbable, Synthetic, Polyamide 2. Equivalent devices Artimplant AB believes the MelonTMSurgical Suture is substantially equivalent to: K993998 T.CAD International - Nylon K98 1582 Sherwood-Davis & Geck - SurgilonB, Ophtalon@and DermalonB Non-… | 2000 |
| * | K981582 | Surgilon, Dermalon, & OphthalonSummary page 1…mide 2. Equivalent devices Artimplant AB believes the MelonTMSurgical Suture is substantially equivalent to: K993998 T.CAD International - Nylon K98 1582 Sherwood-Davis & Geck - SurgilonB, Ophtalon@and DermalonB Non- absorbable Surgical Suture KO03000… | 1998 |
| * | K003000 | Grams Nylon Nonabsorbable Suture | 2000 |
| * | K001173 | Nylon, Nonabsorbable Surgical Sutures Usp | 2000 |
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 |
|---|---|---|---|
| K052482 | Artelon Surgical Suture | 2005 | 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 10 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K052482 (Artimplant AB, 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K993998.
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?
The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032160 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032160: Artelon Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032160
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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