510(k) · Cleared
ClearedSimon Nitinol Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nitinol Medical Technologies, Inc. · DTK Filter, Intravascular, Cardiovascular
Cleared on Apr 20, 1990 after a 270-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 20, 1990
- Review
- 270 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK894703 Simon Nitinol FilterNitinol Medical Technologies, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK963016 Simon Nitinol Filter SystemNitinol Medical Technologies, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK963014 Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK970099 Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K963016Simon Nitinol Filter SystemNitinol Medical Technologies, Inc. · 1996 · cites it directly1descendant
- K963014Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1996 · cites it directly1descendant
- K970099Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1997 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894703 | Simon Nitinol Filter | Nitinol Medical Technologies, Inc. | 1990 | — |
| +1 | K963016 | Simon Nitinol Filter System | Nitinol Medical Technologies, Inc. | 1996 | — |
| +1 | K963014 | Simon Nitinol Filter/Straight Line System | Nitinol Medical Technologies, Inc. | 1996 | — |
| +2 | K970099 | Simon Nitinol Filter/Straight Line System | Nitinol Medical Technologies, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 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? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K963016 (Nitinol Medical Technologies, Inc., 1996) has gone furthest, with 1 descendant 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/K894703 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894703: Simon Nitinol Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894703
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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