510(k) · Cleared
ClearedAln Optional Vana Cava Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aln Implants Chirurgicaux · DTK Filter, Intravascular, Cardiovascular
Cleared on Nov 9, 2012 as substantially equivalent to K912035 (Boston Scientific Corp, 1995) and 3 other predicates after a 385-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 9, 2012
- Review
- 385 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K912035 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK912035 Stainless Steel Green Vena Cava Filt W/12F Intr SYBoston Scientific Corp · 1995
- 1 generation backK070514 Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach…Aln Implants Chirurgicaux · 2008
- This deviceK113124 Aln Optional Vana Cava FilterAln Implants Chirurgicaux · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912035 | Stainless Steel Green Vena Cava Filt W/12F Intr SY | Boston Scientific Corp | 1995 | — |
| −1 | K070514 | Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial… | Aln Implants Chirurgicaux | 2008 | — |
| 0 (this device) | K113124 | Aln Optional Vana Cava Filter | Aln Implants Chirurgicaux | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 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? (4)
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 SYSummary page 2…Filter With 12F Introducer System 5 10(k) Number K 912035 Common Name Permanent Vena Cava Filter Classification Name… | 1995 |
| * | K031328 | Recovery Filter System, Model RF-048FSummary page 2…2: *Trade Name Recovery Conet Removal System 510O(k) Number K 031328 Common Name Vena Cava Filter Classification Name… | 2003 |
| * | K090140 | Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterSummary page 2…: Trade Name Gunther Tulip Vena Cava Filter 5 10(k) Number K 090140 Common Name Vena Cava Filter Classification Name… | 2009 |
| * | K070514 | Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach…Summary page 3…ieval _ __ __ __ _ _ _ _ _ _ _ _ _ _ _ Kit 510(k) Number K 070514 Common Name Vena Cava Filter Classification Name… | 2008 |
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 17 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K912035.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 and the ALN Optional Vena Cava Filter wit Hook is 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…
Read the full statement (193 words)
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter
wit Hook is 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.
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with
Hook may be retrieved according to the instructions supplied in the Instruction
For Use of the ALN Extraction Kit.
The ALN Optional Vena Cava Filter with Hook may be retrieved with a standard
GooseNeck Snare according to the instructions supplied in the Instruction For Use
of this medical device.
Extraction kit: The AIN Optional Vena Cava Filter Extraction Kit has been
designed for the removal of an implanted ALN Optional Vena Cava Filter or ALN
Optional Vena Cava Filter with Hook in patients who no longer require a filter.
The retrieval of the filter can be performed only by jugular approach.
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/K113124 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113124: Aln Optional Vana Cava Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113124
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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