510(k) · Cleared

Cleared

Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060

K041374510(k) TraditionalCleared Mar 2, 2005282-day reviewClass II21 CFR 870.5150

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

Idev Technologies, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on Mar 2, 2005 as substantially equivalent to K030504 (Idev Technologies, Inc., 2003) and 1 other predicate after a 282-day review. Its family tree reaches back 2 generations to 1999. 1 of the 5 devices in its family, counting itself, has a Class I recall.

Decided: Mar 2, 2005
Review: 282 days
Class: Class II
Product code: QEW
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K990829 (1999). 4 ancestors in all, the oldest K970080 (1997). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK990829 Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models…Arrow Intl., Inc. · 1999 · Recalled
1 generation backK011056 Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001 · Recalled (Class I)
This deviceK041374 Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060Idev Technologies, Inc. · 2005

Class I recalls in this family

K011056 Arrow-Trerotola Percutaneous Thrombolytic Device…direct predicate · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990829	Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509…	Arrow Intl., Inc.	1999	1
−1	K011056	Arrow-Trerotola Percutaneous Thrombolytic Device or PTD	Arrow Intl., Inc.	2001	Class I
0 (this device)	K041374	Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060	Idev Technologies, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2003	1	0

FIG. 1 — Lineage of K041374, 1999–2005Source: 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.

1 device in this family has a Class I recall. 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 QEW device

#1 K213402 Triever24, Triever20score 28.6 · 5 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
*	K030504	Akonya Eliminator Mechanical Thrombectomy Device, Model EL 10060060 Summary page 5 …ectomy Catheter Classification Name: Catheter, Embolectomy (21 CFR 870.5150) Product Code: DXE Predicate Device: + AKoénya Eliminator™ Mechanical Thrombectomy Device (K030504) * Arrow-Trerotola ™ Percutancous Thrombolytic Device (PTD) (K011056) Device Description: The AKonya Eliminator Plus™ Mechanical…	Idev Technologies, Inc.	2003	—
*	K011056	Arrow-Trerotola Percutaneous Thrombolytic Device or PTD Summary page 5 …70.5150) Product Code: DXE Predicate Device: + AKoénya Eliminator™ Mechanical Thrombectomy Device (K030504) * Arrow-Trerotola ™ Percutancous Thrombolytic Device (PTD) (K011056) Device Description: The AKonya Eliminator Plus™ Mechanical Thrombectomy Device is comprised of three discrete elements: * An o…	Arrow Intl., Inc.	2001	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K011056Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 111 Class I recalls

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All QEW devices

QEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEW

14in 2025

2007high 23 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEW

58in 2025

2007high 140 (2022) · low 51 (2019)2026

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

Recalls per year · QEW

7in 2022

2007high 7 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · QEW

207in 2025

2007high 322 (2021) · low 0 (2007)2025

MAUDE reports naming product code QEW, 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	0	—	0	0
2008	2	—	0	0
2009	2	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	1	—	0	0
2013	2	—	0	0
2014	2	—	0	0
2015	4	88	0	0
2016	4	63	0	0
2017	2	—	0	0
2018	14	61	0	0
2019	8	51	0	33
2020	16	105	0	197
2021	11	60	0	322
2022	12	140	7 (7)	125
2023	23	102	0	165
2024	14	65	0	162
2025	14	58	0	207
2026	10	74	0	—

What is it indicated for?

The AKénya Eliminator Plus™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting native arterio-venous (AV) fistula and synthetic dialysis grafts.

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/K041374 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041374: Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041374

Report an extraction error

Are you the manufacturer?

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