510(k) · Cleared
Recalled · 2007Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bbraun · DTK Filter, Intravascular, Cardiovascular
Cleared on May 18, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- May 18, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK010485 Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena…Bbraun · 2001
- Descendant · cites it directly · 3 of its ownK152765 Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK173236 Sentry IVC FilterNovate Medical, Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK181202 Sentry IVC FilterNovate Medical, Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K152765Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016 · cites it directly3descendants
- K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 2 generations on2descendants
- K173236Sentry IVC FilterNovate Medical, Ltd. · 2018 · 3 generations on1descendant
- K181202Sentry IVC FilterNovate Medical, Ltd. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010485 | Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave… | Bbraun | 2001 | — |
| +1 | K152765 | Venatech Convertible Vena Cava Filter System | B. Braun Interventional Systems, Inc. | 2016 | — |
| +2 | K162875 | Sentry IVC filter | Novate Medical, Ltd. | 2017 | — |
| +3 | K173236 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
| +4 | K181202 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152765 | Venatech Convertible Vena Cava Filter System | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2007 | Not classified | Z-0264-2008 | Packaging process control | Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152765 (B. Braun Interventional Systems, Inc., 2016) has gone furthest, with 3 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.
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 | — |
https://510kreport.com/device/K010485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010485: Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010485
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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