510(k) · Cleared
ClearedGolnit Nylon Monofilament Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Antarma, LLC Dba Golnit Sutures · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Mar 31, 2022 as substantially equivalent to K161633 (Sm Eng Co., Ltd., 2017) after a 202-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Mar 31, 2022
- Review
- 202 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930586 (1993). 18 ancestors in all, the oldest K902873 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK930586 Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutDavis & Geck, Inc. · 1993
- 4 generations backK981582 Surgilon, Dermalon, & OphthalonDavis & Geck, Inc. · 1998 · Recalled
- 3 generations backK060471 FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006
- 2 generations backK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- 1 generation backK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- This deviceK212888 Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut | Davis & Geck, Inc. | 1993 | — |
| −4 | K981582 | Surgilon, Dermalon, & Ophthalon | Davis & Geck, Inc. | 1998 | 9 |
| −3 | K060471 | FSSB Nylon Surgical Sutures | Fssb Chirurgische Nadeln GmbH | 2006 | — |
| −2 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| −1 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| 0 (this device) | K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K161633 | Rexlon, RexsilSummary page 4…Plastic Surgery Devices (DHT4B) III. PREDICATE DEVICE The Golnit Nylon Monofilament Suture is being compared to the predicate device, REXLON, which was cleared under K161633 and manufactured by SM ENG CO., Ltd. One reference device, the Golnit Non-Absorbable PTFE Surgical Suture, was used to support e… | 2017 |
| † | K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | 2017 |
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?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 3 other devices also cite its predicate K161633.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or 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/K212888 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212888: Golnit Nylon Monofilament Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212888
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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