510(k) · Cleared
ClearedRexlon, Rexsil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sm Eng Co., Ltd. · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Mar 2, 2017 as substantially equivalent to K080684 (Foosin Medical Supplies, Inc., 2008) and 1 other predicate after a 262-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it.
- Decided
- Mar 2, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930586 (1993). 17 ancestors in all, the oldest K902873 (1990). 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK930586 Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutDavis & Geck, Inc. · 1993
- 3 generations backK981582 Surgilon, Dermalon, & OphthalonDavis & Geck, Inc. · 1998 · Recalled
- 2 generations backK060471 FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006
- 1 generation backK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- This deviceK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System…Safepath Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK232355 Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK212888 Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures · 2022
Most influential descendants
Showing 4 of 4 · See all- K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · cites it directly1descendant
- K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc. · 2024 · cites it directly0descendants
- K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024 · cites it directly0descendants
- K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut | Davis & Geck, Inc. | 1993 | — |
| −3 | K981582 | Surgilon, Dermalon, & Ophthalon | Davis & Geck, Inc. | 1998 | 9 |
| −2 | K060471 | FSSB Nylon Surgical Sutures | Fssb Chirurgische Nadeln GmbH | 2006 | — |
| −1 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| 0 (this device) | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +1 | K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 | — |
| +1 | K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide… | Safepath Medical, Inc. | 2024 | — |
| +1 | K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K080684 | WG-Surgical Sutures with NeedleSummary page 8…p. 2 of 9 1.3 Predicate devices Predicate device 01 510(k) Number: K080684 Device Name: WG-Surgical Sutures with Needle Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide… | 2008 |
| * | K982646 | Ailee Sutures and Ailee NeedlesSummary page 8…Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD. Predicate device 02 510(k) Number: K982646 Device Name: Reli Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Manufacturer: AILEE CO LT… | 1999 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K180701 (Safepath Medical, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K080684.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
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/K161633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161633: Rexlon, Rexsil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161633
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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