510(k) · Cleared
ClearedHancock Aortic Punch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hancock Laboratories, Inc. · DWS Instruments, Surgical, Cardiovascular
Cleared on Feb 1, 1980 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 1, 1980
- Review
- 14 days
- Class
- Class I
- Product code
- DWS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK800122 Hancock Aortic PunchHancock Laboratories, Inc. · 1980
- Descendant · cites it directly · 5 of its ownK980128 Baladi Inverter with Coaxial Aortic PunchCardio Medical Solutions, Inc. · 1998
- Descendant · 2 generations on · 4 of its ownK022880 Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp. · 2002 · Recalled
- Descendant · 3 generations on · 3 of its ownK080169 Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008
- Descendant · 4 generations on · 2 of its ownK130382 Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013 · Recalled
- Descendant · 5 generations on · 1 of its ownK203307 VIOLAVascular Graft Solutions, Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K980128Baladi Inverter with Coaxial Aortic PunchCardio Medical Solutions, Inc. · 1998 · cites it directly5descendants
- K022880Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp. · 2002 · 2 generations on4descendants
- K080169Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008 · 3 generations on3descendants
- K130382Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013 · 4 generations on2descendants
- K203307VIOLAVascular Graft Solutions, Ltd. · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K800122 | Hancock Aortic Punch | Hancock Laboratories, Inc. | 1980 | — |
| +1 | K980128 | Baladi Inverter with Coaxial Aortic Punch | Cardio Medical Solutions, Inc. | 1998 | — |
| +2 | K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500 | Guidant Corp. | 2002 | 1 |
| +3 | K080169 | Heartstring Iii Proximal Seal System | Guidant Corporation, Cardiac Surgery | 2008 | — |
| +4 | K130382 | Heartstring Iii Proximal Seal System | Boston Scientific Corporation | 2013 | 3 |
| +5 | K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980128 | Baladi Inverter with Coaxial Aortic Punch | 1998 | 5 |
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, K980128 (Cardio Medical Solutions, Inc., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DWS devicesDWS Instruments, Surgical, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWS
FDA has decided no DWS device since 2007.
Median 510(k) review, days · DWS
Too few DWS 510(k)s in any year since 2007 to give a median.
Recalls per year · DWS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWS
12in 2025
MAUDE reports naming product code DWS, 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 | 0 | — | 0 | 20 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 0 | — | 0 | 44 |
| 2010 | 0 | — | 1 | 27 |
| 2011 | 0 | — | 1 | 55 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 0 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 1 | 33 |
| 2017 | 0 | — | 0 | 40 |
| 2018 | 0 | — | 0 | 60 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 0 | — | 0 | 28 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 0 | — | 1 | 35 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 48 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K800122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K800122: Hancock Aortic Punch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800122
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026