510(k) · Cleared
Recalled · 2006Stainless Steel Greenfield Vena Cava Filter with 12F Introducer 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 Jan 6, 1997 as substantially equivalent to K912035 (Boston Scientific Corp, 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 6, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912035 (1995). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK912035 Stainless Steel Green Vena Cava Filt W/12F Intr SYBoston Scientific Corp · 1995
- This deviceK964284 Stainless Steel Greenfield Vena Cava Filter with 12F Introducer SystemBoston Scientific Corp · 1997
- 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 |
|---|---|---|---|---|---|
| −1 | K912035 | Stainless Steel Green Vena Cava Filt W/12F Intr SY | Boston Scientific Corp | 1995 | — |
| 0 (this device) | K964284 | Stainless Steel Greenfield Vena Cava Filter with 12F Introducer System | Boston Scientific Corp | 1997 | — |
| +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), 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? (1)
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 |
|---|---|---|---|
| * | K912035 | Stainless Steel Green Vena Cava Filt W/12F Intr SY Our OCR of the scanned summary read K912038, FDA’s number for Dash Medical Gloves (Safehealth Labs). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer…”. | 1995 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2006 | Not classified | Z-0794-2007 | Other | One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06. |
| Dec 2, 2005 | Not classified | Z-0280-06 | Other | There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach… |
| Aug 5, 2005 | Not classified | Z-0299-06 | Other | Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is indicated for the prevention of pulmonary embolism via placement in the vena cava in the following situations:
Venous thrombosis or pulmonary thromboembolism when anticoagulants are contraindicated or inadequate for management of venous thrombosis with significant risk of, or following, pulmonary thromboembolism.
Failure of anticoagulant therapy in thromboembolic disease.
Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
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/K964284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964284: Stainless Steel Greenfield Vena Cava Filter with 12F Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964284
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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