510(k) · Cleared
ClearedNYLON
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trading Consultants and Distributors Intl., Inc. · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Feb 4, 2000 after a 72-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Feb 4, 2000
- Review
- 72 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK993998 NYLONTrading Consultants and Distributors Intl., Inc. · 2000
- Descendant · cites it directly · 10 of its ownK060471 FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006
- Descendant · 2 generations on · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K060471FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006 · cites it directly10descendants
- K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · 2 generations on9descendants
- K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 3 generations on4descendants
- K173747RexleneSm Eng Co., Ltd. · 2018 · 3 generations on1descendant
- K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993998 | NYLON | Trading Consultants and Distributors Intl., Inc. | 2000 | — |
| +1 | K060471 | FSSB Nylon Surgical Sutures | Fssb Chirurgische Nadeln GmbH | 2006 | — |
| +2 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +3 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +3 | K173747 | Rexlene | Sm Eng Co., Ltd. | 2018 | — |
| +4 | K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | — | DERMALON® Non-Absorbable Polyamide Surgical Sutures Named without a submission number | |
| * | — | Ethilon® Nonabsorbable Polyamide Surgical Suture Named without a submission number |
What descends from it? (14)
See all 143 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?
- Of its descendants, K060471 (Fssb Chirurgische Nadeln GmbH, 2006) has gone furthest, with 10 descendants of its own.
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?
NYLON is 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/K993998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993998: NYLON.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993998
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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