510(k) · Cleared
ClearedAesculap Dafilon 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 Feb 17, 2016 as substantially equivalent to K990090 (Aesculap, Inc., 1999) and 1 other predicate after a 292-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Feb 17, 2016
- Review
- 292 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954808 (1996). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954808 Ussc Polyproplene SutureUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 2 generations backK050947 Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 2005 · Recalled
- 1 generation backK133890 Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2014
- This deviceK151165 Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK192420 Crownjun Nylon SutureKono Seisakusho Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK221280 VessealLydus Medical, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK212603 Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954808 | Ussc Polyproplene Suture | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| −2 | K050947 | Modification to: Modified Uss Polypropylene Suture | United States Surgical, A Division of Tyco Healthc | 2005 | 2 |
| −1 | K133890 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2014 | — |
| 0 (this device) | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016 | — |
| +1 | K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020 | — |
| +2 | K221280 | Vesseal | Lydus Medical, Ltd. | 2022 | — |
| +1 | K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 11.7 · 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 |
|---|---|---|---|
| * | K990090 | Dafilon Nonabsorbable Polyamide Surgical SutureSummary page 4…orant, two packaging types and extends the available suture length range from 3 cm to 250 cm to the existing product line Dafilon Nonabsorbable Polyamide Surgical Suture K990090. PREDICATE DEVICE Primary Predicate: Dafilon Nonabsorbable Polyamide Surgical Suture (K990090) Aesculap Optil… | 1999 |
| * | K133890 | Aesculap Optilene Nonabsorbable SutureSummary page 4…Suture K990090. PREDICATE DEVICE Primary Predicate: Dafilon Nonabsorbable Polyamide Surgical Suture (K990090) Aesculap Optilene Nonabsorbable Suture (K133890) DEVICE DESCRIPTION Dafilon is a nonabsorbable monofilament surgical suture which is supplied sterile. Dafilon is composed of th… | 2014 |
What descends from it? (3)
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)
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 20 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K192420 (Kono Seisakusho Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K990090.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Dafilon Nonabsorbable Polyamide Surgical Sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151165
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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