510(k) · Cleared
ClearedCardica Pas-Port Proximal Anastomosis System, Model FG-000001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardica, Inc. · FZP Clip, Implantable
Cleared on Apr 29, 2009 as substantially equivalent to K081225 (Cardica, Inc., 2008) after a 20-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Apr 29, 2009
- Review
- 20 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970793 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK970793 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1997
- 2 generations backK003446 Symmetry Aortic Clip SystemSt. Jude Medical Cardiovascular Group, Inc. · 2001
- 1 generation backK081225 Cardica Pas-Port Proximal Anastomosis SystemCardica, Inc. · 2008
- This deviceK091017 Cardica Pas-Port Proximal Anastomosis System, Model FG-000001Cardica, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK202124 Aesculap PAS-Port Proximal Anastomosis SystemAesculap, Inc. · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K202124Aesculap PAS-Port Proximal Anastomosis SystemAesculap, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970793 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −2 | K003446 | Symmetry Aortic Clip System | St. Jude Medical Cardiovascular Group, Inc. | 2001 | — |
| −1 | K081225 | Cardica Pas-Port Proximal Anastomosis System | Cardica, Inc. | 2008 | — |
| 0 (this device) | K091017 | Cardica Pas-Port Proximal Anastomosis System, Model FG-000001 | Cardica, Inc. | 2009 | — |
| +1 | K202124 | Aesculap PAS-Port Proximal Anastomosis System | Aesculap, Inc. | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K081225 | Cardica Pas-Port Proximal Anastomosis SystemSummary page 2…e PAS-Port® Proximal Anastomosis System is substantially Predicate Device equivalent to the PAS-Port® Proximal Anastomosis System (K081225, 21 CFR §878.4300). Device Testing All necessary in vitro and in vivo testing has been performed Results and… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | 2020 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K202124 (Aesculap, Inc., 2020) has gone furthest, with 0 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. 2009, this device’s year, is highlighted.
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 Cardica® PAS-Port® Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091017: Cardica Pas-Port Proximal Anastomosis System, Model FG-000001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091017
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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