510(k) · Cleared
ClearedCorlink Automated Anastomotic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
By-Pass Makafim, Ltd. · FZP Clip, Implantable
Cleared on Mar 31, 2004 as substantially equivalent to K020470 (Bypass, Ltd., 2002) after a 99-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Mar 31, 2004
- Review
- 99 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864146 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK864146 Deknatel Gwathmey Vascular Stapling Kit (Tenative)Cardio Thoracic Systems · 1986
- 2 generations backK011589 Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064…Bypass, Ltd. · 2001
- 1 generation backK020470 Modification to Corlink Automated Anastomotic DeviceBypass, Ltd. · 2002
- This deviceK033979 Corlink Automated Anastomotic SystemBy-Pass Makafim, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864146 | Deknatel Gwathmey Vascular Stapling Kit (Tenative) | Cardio Thoracic Systems | 1986 | — |
| −2 | K011589 | Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad… | Bypass, Ltd. | 2001 | — |
| −1 | K020470 | Modification to Corlink Automated Anastomotic Device | Bypass, Ltd. | 2002 | — |
| 0 (this device) | K033979 | Corlink Automated Anastomotic System | By-Pass Makafim, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K020470 | Modification to Corlink Automated Anastomotic DeviceSummary page 1…g the aortotomy in which the implanted device will be deployed. The Coring punch device is equivalent to the punch already cleared as a component of the CorLinkTM AAS (K020470) with respect to intended use. The major differences between the two systems are: 1. The Piercing Tip and the Tissue Grabbe… | 2002 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 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.
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 CorLink AAS is indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG). The Coring punch component penetrates the aorta and cuts a circumferential aortotomy in which the implanted device will be deployed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033979: Corlink Automated Anastomotic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033979
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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