510(k) · Cleared
Recalled · Class II · 2021Aesculap PAS-Port Proximal Anastomosis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · FZP Clip, Implantable
Cleared on Sep 2, 2020 as substantially equivalent to K091017 (Cardica, Inc., 2009) after a 33-day review. Its family tree reaches back 4 generations to 1997. It has been recalled 2 times.
- Decided
- Sep 2, 2020
- Review
- 33 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970793 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK970793 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1997
- 3 generations backK003446 Symmetry Aortic Clip SystemSt. Jude Medical Cardiovascular Group, Inc. · 2001
- 2 generations backK081225 Cardica Pas-Port Proximal Anastomosis SystemCardica, Inc. · 2008
- 1 generation backK091017 Cardica Pas-Port Proximal Anastomosis System, Model FG-000001Cardica, Inc. · 2009
- This deviceK202124 Aesculap PAS-Port Proximal Anastomosis SystemAesculap, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970793 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −3 | K003446 | Symmetry Aortic Clip System | St. Jude Medical Cardiovascular Group, Inc. | 2001 | — |
| −2 | K081225 | Cardica Pas-Port Proximal Anastomosis System | Cardica, Inc. | 2008 | — |
| −1 | K091017 | Cardica Pas-Port Proximal Anastomosis System, Model FG-000001 | Cardica, Inc. | 2009 | — |
| 0 (this device) | K202124 | Aesculap PAS-Port Proximal Anastomosis System | Aesculap, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K091017 | Cardica Pas-Port Proximal Anastomosis System, Model FG-000001Summary page 4…NUMBER: 878.4300 PRODUCT CODE: FZP DEVICE CLASS: Class II per 21 CFR 878.4300 PREDICATE DEVICE PAS-Port Proximal Anastomosis System (K091017) DEVICE DESCRIPTION The Aesculap PAS-Port Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein… | 2009 |
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 |
|---|---|---|---|---|
| Apr 16, 2021 | Class II | Z-2578-2021 | Under Investigation by firm | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery |
| Apr 16, 2021 | Class II | Z-2579-2021 | Under Investigation by firm | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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/K202124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202124: Aesculap PAS-Port Proximal Anastomosis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202124
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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