510(k) · Cleared
Recalled · Class II · 2014Dafilon Nonabsorbable Polyamide Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Mar 22, 1999 after a 70-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- GAR
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK990090 Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK151165 Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK192420 Crownjun Nylon SutureKono Seisakusho Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK221280 VessealLydus Medical, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK212603 Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK060528 Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical SutureAesculap, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 2016 · cites it directly3descendants
- K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd. · 2020 · 2 generations on1descendant
- K221280VessealLydus Medical, Ltd. · 2022 · 3 generations on0descendants
- K212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. · 2021 · 2 generations on0descendants
- K060528Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical SutureAesculap, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990090 | Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 1999 | — |
| +1 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016 | — |
| +2 | K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020 | — |
| +3 | K221280 | Vesseal | Lydus Medical, Ltd. | 2022 | — |
| +2 | K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021 | — |
| +1 | K060528 | Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical Suture | Aesculap, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | — | Ethilon® Nonabsorbable Polyamide Surgical Suture Named without a submission number | |
| * | — | DERMALON® Nonabsorbable Polyamide Surgical Suture Named without a submission number | |
| * | — | MONOSOF® Nonabsorbable Polyamide Surgical Suture Named without a submission number |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 13, 2014 | Class II | Z-2024-2014 | Labeling design | Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151165 (Aesculap, Inc., 2016) has gone furthest, with 3 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?
Dafilon® sutures are intended 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/K990090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990090: Dafilon Nonabsorbable Polyamide Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990090
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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