510(k) · Cleared
ClearedVenatech Convertible Vena Cava Filter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun Interventional Systems, Inc. · DTK Filter, Intravascular, Cardiovascular
Cleared on Feb 26, 2016 as substantially equivalent to K010485 (Bbraun, 2001) and 1 other predicate after a 155-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Feb 26, 2016
- Review
- 155 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010485 (2001). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK010485 Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena…Bbraun · 2001 · Recalled
- This deviceK152765 Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK173236 Sentry IVC FilterNovate Medical, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK181202 Sentry IVC FilterNovate Medical, Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010485 | Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave… | Bbraun | 2001 | 1 |
| 0 (this device) | K152765 | Venatech Convertible Vena Cava Filter System | B. Braun Interventional Systems, Inc. | 2016 | — |
| +1 | K162875 | Sentry IVC filter | Novate Medical, Ltd. | 2017 | — |
| +2 | K173236 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
| +3 | K181202 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 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 DTK? 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 DTK device
- #1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 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? (2)
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 |
|---|---|---|---|
| * | K010485 | Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave FilterSummary page 4…cular Intravascular Filter (21 CFR 870.3375; Class II) Information ProCode: DTK; Panel: Cardiovascular Predicate VenaTech LP Vena Cava Filter System (K010485, K063217) Reference Device VenaTech LGM Vena Cava Filter System (K881604, K901454, K925679, K932921) Device Desc… | 2001 |
| * | K063217 | Venatech LP Brachial Introducer System (Antecubital)Summary page 4…ravascular Filter (21 CFR 870.3375; Class II) Information ProCode: DTK; Panel: Cardiovascular Predicate VenaTech LP Vena Cava Filter System (K010485, K063217) Reference Device VenaTech LGM Vena Cava Filter System (K881604, K901454, K925679, K932921) Device Description T… | 2007 |
| † | K881604 | Vena Cava Filter | 1989 |
| † | K901454 | Vena Cava Filter | 1991 |
| † | K925679 | Vena Cava Filter Systems, Modification | 1992 |
| † | K932921 | Percutaneous Introducer for Vena Cava Filter Syst | 1993 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162875 | Sentry IVC filter | 2017 | 2 |
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?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K162875 (Novate Medical, Ltd., 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DTK
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DTK
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTK
432in 2025
MAUDE reports naming product code DTK, 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 | 3 | 87 | 1 | 364 |
| 2008 | 6 | 87 | 0 | 345 |
| 2009 | 3 | 380 | 0 | 456 |
| 2010 | 3 | 50 | 0 | 369 |
| 2011 | 2 | — | 0 | 439 |
| 2012 | 5 | 156 | 0 | 351 |
| 2013 | 3 | 91 | 1 | 473 |
| 2014 | 2 | — | 0 | 451 |
| 2015 | 2 | — | 1 | 859 |
| 2016 | 3 | 84 | 2 | 2,574 |
| 2017 | 5 | 88 | 0 | 4,364 |
| 2018 | 2 | — | 0 | 3,938 |
| 2019 | 0 | — | 6 | 6,467 |
| 2020 | 0 | — | 0 | 5,405 |
| 2021 | 2 | — | 0 | 5,357 |
| 2022 | 0 | — | 2 | 2,191 |
| 2023 | 0 | — | 0 | 583 |
| 2024 | 5 | 29 | 0 | 406 |
| 2025 | 0 | — | 1 | 432 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VenaTech® Convertible™ Vena Cava Filter System is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated; • Failure of anticoagulant therapy in thromboembolic diseases; • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and • Chronic, recurrent…
Read the full statement (99 words)
The VenaTech® Convertible™ Vena Cava Filter System is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
• Pulmonary thromboembolism when anticoagulants are contraindicated;
• Failure of anticoagulant therapy in thromboembolic diseases;
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
When clinically indicated after implantation, the VenaTech Convertible filter can be converted to an open configuration to discontinue filtration according to the ‘Conversion Procedure’ in the Instructions for Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152765: Venatech Convertible Vena Cava Filter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152765
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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