510(k) · Cleared
ClearedALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aln S.A.R.L. · DTK Filter, Intravascular, Cardiovascular
Cleared on Jun 26, 2024 as substantially equivalent to K163699 (Aln Implants Chirurgicaux, 2017) after a 29-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Jun 26, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K163699 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backK163699 ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena…Aln Implants Chirurgicaux · 2017
- This deviceK241507 ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096…Aln S.A.R.L. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava… | Aln Implants Chirurgicaux | 2017 | — |
| 0 (this device) | K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK… | Aln S.A.R.L. | 2024 | — |
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 |
|---|---|---|---|
| * | K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter -…Summary page 6…ALN Optional Vena Cava Filter: Trade Name ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit 510(k) Number K163699 Common Name Vena Cava Filter and Extraction Kit Classification Name Cardiovascular Intravascular… | 2017 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 ALN Optional Vena Cava Filter with Hook and without Hook are indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy in thromboembolic diseases, - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and - Chronic…
Read the full statement (132 words)
The ALN Optional Vena Cava Filter with Hook and without Hook are indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated,
- Failure of anticoagulant therapy in thromboembolic diseases,
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
ALN Optional Vena Cava Filters with Hook and without Hook, may be retrieved with the ALN Extraction and /or Repositioning Kits according to the Instructions For Use of these devices.
The ALN Optional Vena Cava Filter with Hook may be also retrieved with a standard GooseNeck Snare according to the the Instructions For Use of this medical device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241507 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241507: ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241507
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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