510(k) · Cleared

Cleared

ICHOR 7F Embolectomy System (ICH-7F)

K233917510(k) TraditionalCleared Jul 18, 2024219-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

Ichor · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on Jul 18, 2024 as substantially equivalent to K182167 (Ichor Vascular, Inc., 2018) after a 219-day review. Its family tree reaches back 2 generations to 2017.

Decided: Jul 18, 2024
Review: 219 days
Class: Class II
Product code: QEW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K171493 (2017). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK171493 MegaVac Mechanical Thrombectomy SystemCapture Vascular, Inc. · 2017
1 generation backK182167 The ICHOR Panacea Vascular Embolectomy Catheter SystemIchor Vascular, Inc. · 2018
This deviceK233917 ICHOR 7F Embolectomy System (ICH-7F)Ichor · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K171493	MegaVac Mechanical Thrombectomy System	Capture Vascular, Inc.	2017	—
−1	K182167	The ICHOR Panacea Vascular Embolectomy Catheter System	Ichor Vascular, Inc.	2018	—
0 (this device)	K233917	ICHOR 7F Embolectomy System (ICH-7F)	Ichor	2024	—

FIG. 1 — Lineage of K233917, 2017–2024Source: 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 QEW? 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

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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	Applicant	Decided	Recalls
*	K182167	The ICHOR Panacea Vascular Embolectomy Catheter System Summary page 5 …age 2 of 4 D. Predicate Device Names Predicate Device: ICHOR Panacea Vascular Embolectomy Catheter System Predicate #: K182167 Predicate Product Code: QEW E. Device Description Summary The ICHOR 7F Embolectomy System is indicated for the no…	Ichor Vascular, Inc.	2018	—

Also cleared against K182167: 1 other device →

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 3 companies; a new generation was cleared every 5.6 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K182167.

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. 2024, this device’s year, is highlighted.

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 ICHOR 7F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K233917 · printed Nov 6, 2026

Cite this page

510(k) Report. “K233917: ICHOR 7F Embolectomy System (ICH-7F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233917

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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