510(k) · Cleared
ClearedAesculap Optilene Nonabsorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Jul 15, 2014 as substantially equivalent to K980703 (Aesculap, Inc., 1998) and 3 other predicates after a 207-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it.
- Decided
- Jul 15, 2014
- Review
- 207 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K954808 (1996). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954808 Ussc Polyproplene SutureUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 1 generation backK050947 Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 2005 · Recalled
- This deviceK133890 Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2014
- 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 ownK180321 Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2018
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
- K180321Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954808 | Ussc Polyproplene Suture | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| −1 | K050947 | Modification to: Modified Uss Polypropylene Suture | United States Surgical, A Division of Tyco Healthc | 2005 | 2 |
| 0 (this device) | K133890 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2014 | — |
| +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 | K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980703 | Premilene Nonabsorbable Polypropylene Surgical SutureSummary page 1…ene Nonabsorbable Polypropylene/Polyethylene Surgical Suture is substantially equivalent to: " Premilene Nonabsorbable Polypropylene Surgical Suture, Aesculap, Inc. (K980703) * Prolene Polypropylene Nonabsorbable Surgical Suture, Ethicon Inc. (N 16374) * USS Polypropylene Suture, United States… | 1998 |
| Kept off the family tree | K016374 | Prolene Polypropylene Nonabsorbable Surgical Suture Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K050947 | Modification to: Modified Uss Polypropylene SutureSummary page 1…uture, Aesculap, Inc. (K980703) * Prolene Polypropylene Nonabsorbable Surgical Suture, Ethicon Inc. (N 16374) * USS Polypropylene Suture, United States Surgical (K050947/KO010909/K954808) The Optilene Nonabsorbable Polypropylene/Polyethylene Surgical Suture pledget is substantially equivalent to:… | 2005 |
| Kept off the family tree | K001909 | FDA’s K001909 is Plainsense Wheelchair Our OCR of the scanned summary read K001909, FDA’s number for Plainsense Wheelchair (Plainsense Wheelchairs, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “USS Polypropylene Suture”. Kept off the family tree. | 2000 |
| * | K954808 | Ussc Polyproplene SutureSummary page 1…Inc. (K980703) * Prolene Polypropylene Nonabsorbable Surgical Suture, Ethicon Inc. (N 16374) * USS Polypropylene Suture, United States Surgical (K050947/KO010909/K954808) The Optilene Nonabsorbable Polypropylene/Polyethylene Surgical Suture pledget is substantially equivalent to: e PremiCron No… | 1996 |
| * | K012201 | Premicron Nonabsorbable Pet Surgical SutureSummary page 1…ptilene Nonabsorbable Polypropylene/Polyethylene Surgical Suture pledget is substantially equivalent to: e PremiCron Nonabsorable PET Surgical Suture, Aesculap Inc. (K012201) DEVICE DESCRIPTION Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of… | 2001 |
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)
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 18 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K151165 (Aesculap, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K980703.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and 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/K133890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133890: Aesculap Optilene Nonabsorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133890
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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