510(k) · Cleared

Cleared

Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach, Extraction Kit, Precurved Extractio

K070514510(k) AbbreviatedCleared Jan 30, 2008342-day reviewClass II21 CFR 870.3375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aln Implants Chirurgicaux · DTK Filter, Intravascular, Cardiovascular

Cleared on Jan 30, 2008 as substantially equivalent to K912035 (Boston Scientific Corp, 1995) and 1 other predicate after a 342-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Jan 30, 2008
Review: 342 days
Class: Class II
Product code: DTK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K912035 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK912035 Stainless Steel Green Vena Cava Filt W/12F Intr SYBoston Scientific Corp · 1995
This deviceK070514 Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach…Aln Implants Chirurgicaux · 2008
Descendant · cites it directly · 0 of its ownK113124 Aln Optional Vana Cava FilterAln Implants Chirurgicaux · 2012

Most influential descendants

Showing 1 of 1 · See all

K113124Aln Optional Vana Cava FilterAln Implants Chirurgicaux · 2012 · cites it directly0descendants

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)	K070514	Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial…	Aln Implants Chirurgicaux	2008	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K070514, 1995–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K912035	Stainless Steel Green Vena Cava Filt W/12F Intr SY Summary page 2 …ava Filter With 12F Introducer System 510(k) Number K912035 Common Name Permanent Vena Cava Filter Classification Name…	Boston Scientific Corp	1995	—
*	K031328	Recovery Filter System, Model RF-048F Summary page 2 …device 2: Trade Name Recovery Cone® Removal System 510(k) Number K 031328 Common Name Vena Cava Filter Classification Name…	C.R. Bard, Inc.	2003	—

Also cleared against K912035: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113124	Aln Optional Vana Cava Filter	Aln Implants Chirurgicaux	2012	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K113124 (Aln Implants Chirurgicaux, 2012) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K912035.

How does its category compare?

All DTK devices

DTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DTK

5in 2024

2007high 6 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTK

29in 2024

2007high 380 (2009) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTK

1in 2025

2007high 6 (2019) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTK

432in 2025

2007high 6,467 (2019) · low 345 (2008)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 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…

Read the full statement (137 words)

The ALN Optional Vena Cava Filter 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 may be retrieved according to the

instructions supplied in the Instruction For Use of the ALN Extraction Kit.

Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been

designed for the removal of an implanted ALN Optional Vena Cava Filter in

patients who no longer require a filter. The retrieval of the filter can be performed

only by jugular approach.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070514 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070514: Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach, Extraction Kit, Precurved Extractio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070514

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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