510(k) · Cleared
Recalled · Class II · 2016Edwards Suture Fastening System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · HCF Instrument, Ligature Passing And Knot Tying
Cleared on Jun 16, 2015 as substantially equivalent to K141206 (Edwards Lifesciences, LLC, 2015) after a 75-day review. Its family tree reaches back 6 generations to 1993. It has been recalled once.
- Decided
- Jun 16, 2015
- Review
- 75 days
- Class
- Class I
- Product code
- HCF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933887 (1993). 16 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.
- Root · 6 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 5 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 4 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 3 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 2 generations backK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
- 1 generation backK141206 Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015
- This deviceK150882 Edwards Suture Fastening SystemEdwards Lifesciences, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −5 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −4 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −3 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −2 | K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | Lsi Solutions, Inc. | 2010 | — |
| −1 | K141206 | Edwards Lifesciences Thruport Knotting System | Edwards Lifesciences, LLC | 2015 | — |
| 0 (this device) | K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 HCF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K141206 | Edwards Lifesciences Thruport Knotting SystemSummary page 4…ng, General & Plastic Surgery Panel (21 CFR §878.4800, Product Code HCF, Class I) Predicate Device: K141206, Edwards ThruPort OptiClip Knotting System, Edwards Lifesciences, LLC. Device Description The E… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2016 | Class II | Z-1575-2016 | Unknown/Undetermined by firm | Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 16 ancestors have a recall of any class.
How does its category compare?
All HCF devicesHCF Instrument, Ligature Passing And Knot Tying: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HCF
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HCF
Too few HCF 510(k)s in any year since 2007 to give a median.
Recalls per year · HCF
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCF
78in 2025
MAUDE reports naming product code HCF, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 0 | — | 1 | 10 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 66 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 27 |
| 2021 | 0 | — | 0 | 46 |
| 2022 | 0 | — | 0 | 68 |
| 2023 | 0 | — | 2 | 57 |
| 2024 | 0 | — | 0 | 124 |
| 2025 | 0 | — | 0 | 78 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards’ surgical heart valves and annuloplasty rings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150882: Edwards Suture Fastening System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150882
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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