510(k) · Cleared
ClearedIvs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Vascular Systems, Inc. · FZP Clip, Implantable
Cleared on Sep 25, 2002 after a 191-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 25, 2002
- Review
- 191 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK020879 Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs…Integrated Vascular Systems, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK030723 Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK060902 Starclose Introducer Set Model- 1002Abbott Vascular, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK051125 Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677Abbott Laboratories · 2005
- Descendant · 2 generations on · 0 of its ownK031583 Modification to Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K030723Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc. · 2003 · cites it directly2descendants
- K060902Starclose Introducer Set Model- 1002Abbott Vascular, Inc. · 2006 · 2 generations on0descendants
- K051125Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677Abbott Laboratories · 2005 · cites it directly0descendants
- K031583Modification to Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020879 | Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set… | Integrated Vascular Systems, Inc. | 2002 | — |
| +1 | K030723 | Ivs Introducer Set, Model 1003 | Integrated Vascular Systems, Inc. | 2003 | — |
| +2 | K060902 | Starclose Introducer Set Model- 1002 | Abbott Vascular, Inc. | 2006 | 1 |
| +1 | K051125 | Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677 | Abbott Laboratories | 2005 | — |
| +2 | K031583 | Modification to Ivs Introducer Set, Model 1003 | Integrated Vascular Systems, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 FZP? 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 FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | Angiolink EVSTM Vascular Closure System Named without a submission number |
What descends from it? (4)
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?
- Of its descendants, K030723 (Integrated Vascular Systems, Inc., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, 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 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.
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/K020879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020879: Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020879
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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