510(k) · Cleared
ClearedStainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier Introducter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DTK Filter, Intravascular, Cardiovascular
Cleared on Feb 9, 1996 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 9, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK955396 Stainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier…Boston Scientific Corp · 1996
- Descendant · cites it directly · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009
- Descendant · 2 generations on · 2 of its ownK133243 Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK120402 Crux Vena Cava Filter SystemCrux Biomedical · 2012
- Descendant · 3 generations on · 1 of its ownK143405 Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P. · 2015
- Descendant · 3 generations on · 1 of its ownK122585 Crux Vena Cava Filter SystemCrux Biomedical · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K081410Option Vena Cava FilterRex Medical · 2009 · cites it directly6descendants
- K133243Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · 2 generations on2descendants
- K120402Crux Vena Cava Filter SystemCrux Biomedical · 2012 · 2 generations on2descendants
- K143405Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P. · 2015 · 3 generations on1descendant
- K122585Crux Vena Cava Filter SystemCrux Biomedical · 2013 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955396 | Stainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier Introducter… | Boston Scientific Corp | 1996 | — |
| +1 | K081410 | Option Vena Cava Filter | Rex Medical | 2009 | — |
| +2 | K133243 | Option Elite Vena Cava Filter System | Rex Medical, L.P. | 2013 | 2 |
| +2 | K120402 | Crux Vena Cava Filter System | Crux Biomedical | 2012 | — |
| +3 | K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | Rex Medical, L.P. | 2015 | — |
| +3 | K122585 | Crux Vena Cava Filter System | Crux Biomedical | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2024 | 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 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081410 | Option Vena Cava Filter | 2009 | 6 |
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, K081410 (Rex Medical, 2009) has gone furthest, with 6 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/K955396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955396: Stainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier Introducter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955396
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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