510(k) · Cleared
ClearedVesseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lydus Medical, Ltd. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Dec 9, 2022 as substantially equivalent to K192420 (Kono Seisakusho Co., Ltd., 2020) and 1 other predicate after a 220-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Dec 9, 2022
- Review
- 220 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954808 (1996). 16 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.
- Root · 5 generations backK954808 Ussc Polyproplene SutureUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 4 generations backK050947 Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 2005 · Recalled
- 3 generations backK133890 Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2014
- 2 generations backK151165 Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 2016
- 1 generation backK192420 Crownjun Nylon SutureKono Seisakusho Co., Ltd. · 2020
- This deviceK221280 VessealLydus Medical, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954808 | Ussc Polyproplene Suture | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| −4 | K050947 | Modification to: Modified Uss Polypropylene Suture | United States Surgical, A Division of Tyco Healthc | 2005 | 2 |
| −3 | K133890 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2014 | — |
| −2 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016 | — |
| −1 | K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020 | — |
| 0 (this device) | K221280 | Vesseal | Lydus Medical, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 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? (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 |
|---|---|---|---|
| * | K192420 | Crownjun Nylon SutureSummary page 4…sseal Device Common Name: Suture, Nonabsorbable, Synthetic, Polyamide Classification: 21 CFR 878.5020 Class: Class II Product Code: GAR III. PREDICATE DEVICE • K192420, Kono Seisakusho Co., Ltd. Crownjun Nylon Suture • K013683, Abbott Vascular Suture Anastomosis device IV. DEVICE DESCRI… | 2020 |
| * | K013683 | Modification to: Abbott Vascular Suture Anastomosis DeviceSummary page 4…amide Classification: 21 CFR 878.5020 Class: Class II Product Code: GAR III. PREDICATE DEVICE • K192420, Kono Seisakusho Co., Ltd. Crownjun Nylon Suture • K013683, Abbott Vascular Suture Anastomosis device IV. DEVICE DESCRIPTION The Vesseal is a hand-held device, enabling simultaneous… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 16 ancestors have a recall of any class.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the
creation of a vascular anastomosis in arteries of 2-4mm in diameter.
It is not intended for use in coronary artery grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221280: Vesseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221280
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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