510(k) · Cleared
ClearedBaladi Inverter with Coaxial Aortic Punch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Medical Solutions, Inc. · DXC Clamp, Vascular
Cleared on Jul 24, 1998 as substantially equivalent to K800122 (Hancock Laboratories, Inc., 1980) after a 191-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it.
- Decided
- Jul 24, 1998
- Review
- 191 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K800122 (1980). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK800122 Hancock Aortic PunchHancock Laboratories, Inc. · 1980
- This deviceK980128 Baladi Inverter with Coaxial Aortic PunchCardio Medical Solutions, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK022880 Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp. · 2002 · Recalled
- Descendant · 2 generations on · 3 of its ownK080169 Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008
- Descendant · 3 generations on · 2 of its ownK130382 Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK203307 VIOLAVascular Graft Solutions, Ltd. · 2021
- Descendant · 5 generations on · 0 of its ownK230248 VIOLAVascular Graft Solutions, Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K022880Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp. · 2002 · cites it directly4descendants
- K080169Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008 · 2 generations on3descendants
- K130382Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013 · 3 generations on2descendants
- K203307VIOLAVascular Graft Solutions, Ltd. · 2021 · 4 generations on1descendant
- K230248VIOLAVascular Graft Solutions, Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800122 | Hancock Aortic Punch | Hancock Laboratories, Inc. | 1980 | — |
| 0 (this device) | K980128 | Baladi Inverter with Coaxial Aortic Punch | Cardio Medical Solutions, Inc. | 1998 | — |
| +1 | K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500 | Guidant Corp. | 2002 | 1 |
| +2 | K080169 | Heartstring Iii Proximal Seal System | Guidant Corporation, Cardiac Surgery | 2008 | — |
| +3 | K130382 | Heartstring Iii Proximal Seal System | Boston Scientific Corporation | 2013 | 3 |
| +4 | K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021 | — |
| +5 | K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K800122 | Hancock Aortic PunchSummary page 2…ing the completion of the anastomosis during CABG procedures. H. Predicate Devices Debakey Vascular Clamp Cooley Vascular Clamp Medtronic Punch Hancock Aortic Punch (K800122) Davis + Geck CardioPunch I. Summary of Non-Clinical Testing The Baladi Inverter™ with Coaxial Aortic Punch has undergone all of… | 1980 |
| * | — | Debakey Vascular Clamp Named without a submission number | |
| * | — | Cooley Vascular Clamp Named without a submission number | |
| * | — | Medtronic Punch Named without a submission number | |
| * | — | Davis + Geck CardioPunch Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500 | 2002 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K022880 (Guidant Corp., 2002) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The Baladi Inverter™ with Coaxial Aortic Punch is intended for use by cardiac surgeons during Coronary Artery Bypass Grafting procedures to maintain hemostasis and punch a hole in the aorta to facilitate the completion of the proximal anastomosis.
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/K980128 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980128: Baladi Inverter with Coaxial Aortic Punch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980128
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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