510(k) · Cleared
ClearedSimon Nitinol Filter/Straight Line System
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 16, 1997 as substantially equivalent to K963014 (Nitinol Medical Technologies, Inc., 1996) and 1 other predicate after a 93-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 16, 1997
- Review
- 93 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894703 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK894703 Simon Nitinol FilterNitinol Medical Technologies, Inc. · 1990
- 1 generation backK963014 Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1996
- This deviceK970099 Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894703 | Simon Nitinol Filter | Nitinol Medical Technologies, Inc. | 1990 | — |
| −1 | K963014 | Simon Nitinol Filter/Straight Line System | Nitinol Medical Technologies, Inc. | 1996 | — |
| 0 (this device) | K970099 | Simon Nitinol Filter/Straight Line System | Nitinol Medical Technologies, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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? (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 |
|---|---|---|---|
| * | K963014 | Simon Nitinol Filter/Straight Line SystemSummary page 2…lter Common Name Vena Cava Filter System Product Code DTK 0000172 Predicate Devices 1. Simon Nitinol Filter/StraightLine™ System (“SNF/SL System”) (K963014) and Simon Nitinol Filter™ System (“SNF System”) (K963016). Intended Use The intended use of both Systems is to prevent embolis… | 1996 |
| * | K963016 | Simon Nitinol Filter SystemSummary page 2…DTK 0000172 Predicate Devices 1. Simon Nitinol Filter/StraightLine™ System (“SNF/SL System”) (K963014) and Simon Nitinol Filter™ System (“SNF System”) (K963016). Intended Use The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries. Substantial… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 6.6 years on median.
- None of the 6 ancestors has a recall.
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 intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.
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/K970099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970099: Simon Nitinol Filter/Straight Line System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970099
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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