510(k) · Cleared
Recalled · Class II · 2021Adult Vent Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dlp, Inc. · DRA Catheter, Steerable
Cleared on Jan 27, 1984 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 27, 1984
- Review
- 45 days
- Class
- Class II
- Product code
- DRA
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK834352 Adult Vent CatheterDlp, Inc. · 1984
- Descendant · cites it directly · 0 of its ownK200289 Michler-Kapp Cardiovascular Vent CatheterKapp Surgical Instrument, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK170488 Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular…Surge Cardiovascular · 2017
- Descendant · cites it directly · 0 of its ownK012143 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 2001
Most influential descendants
Showing 3 of 3 · See all- K200289Michler-Kapp Cardiovascular Vent CatheterKapp Surgical Instrument, Inc. · 2021 · cites it directly0descendants
- K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr…Surge Cardiovascular · 2017 · cites it directly0descendants
- K01214324 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524Medtronic Cardiac Surgical Products · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K834352 | Adult Vent Catheter | Dlp, Inc. | 1984 | — |
| +1 | K200289 | Michler-Kapp Cardiovascular Vent Catheter | Kapp Surgical Instrument, Inc. | 2021 | — |
| +1 | K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent… | Surge Cardiovascular | 2017 | — |
| +1 | K012143 | 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524 | Medtronic Cardiac Surgical Products | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2021 | Class II | Z-2504-2021 | Process control | Potential for a wire protrusion through the left heart vent catheter tip |
| Aug 24, 2021 | Class II | Z-2505-2021 | Process control | Potential for a wire protrusion through the left heart vent catheter tip |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200289 (Kapp Surgical Instrument, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
https://510kreport.com/device/K834352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K834352: Adult Vent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K834352
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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