510(k) · Cleared
ClearedHeartport Endopulmonary Vent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartport, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 18, 1996 as substantially equivalent to K845046 (Dlp, Inc., 1985) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Jun 18, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811411 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK811411 Swan-Ganz Heparin Coated, Etc. CatheterAmerican Edwards Laboratories · 1981
- This deviceK961245 Heartport Endopulmonary VentHeartport, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK962858 Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem…Heartport, Inc. · 1996
Most influential descendants
Showing 1 of 1 · See all- K962858Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number…Heartport, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811411 | Swan-Ganz Heparin Coated, Etc. Catheter | American Edwards Laboratories | 1981 | — |
| 0 (this device) | K961245 | Heartport Endopulmonary Vent | Heartport, Inc. | 1996 | — |
| +1 | K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog… | Heartport, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K845046 | Pul,Monary Artery Vent CatheterSummary page 1…eter Classification Name: Cardiopulmonary bypass catheter Equivalent Devices: Name: Pulmonary Artery Vent Catheter Manufacturer: DLP Status: Post-enactment 510(k) # K845046 Name: Edslab Pulmonary Artery Catheter Manufacturer: Baxter Healthcare Corporation Status: Pre-enactment 510(k) # not applicabl… | 1985 |
| * | K811411 | Swan-Ganz Heparin Coated, Etc. CatheterSummary page 1…actment 510(k) # not applicable Name: Swan-Ganz® Heparin Coated, Pulmonary Artery Catheter Manufacturer: Baxter Healthcare Corporation Status: Post-enactment 510(k) # K811411 Heartport, Inc. 13 CONFIDENTIAL Endopulmonary Vent 310(k) Summary of Safety and Effectiveness (continued) Int… | 1981 |
| * | — | Edslab Pulmonary Artery Catheter Named without a submission number |
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 |
|---|---|---|---|
| K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number… | 1996 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K962858 (Heartport, Inc., 1996) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.
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/K961245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961245: Heartport Endopulmonary Vent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961245
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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