510(k) · Cleared

Cleared

Recruit Microcatheter

K091563510(k) TraditionalCleared Jul 30, 200963-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

Reverse Medical Corporation · MMX Device, Percutaneous Retrieval

Cleared on Jul 30, 2009 as substantially equivalent to K014109 (Boston Scientific, Target, 2002) after a 63-day review. Its family tree reaches back 2 generations to 1991.

Decided: Jul 30, 2009
Review: 63 days
Class: Class II
Product code: MMX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K914067 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK914067 Retrieval DeviceTarget Therapeutics · 1991
1 generation backK014109 IN-Time Retrieval DeviceBoston Scientific, Target · 2002
This deviceK091563 Recruit MicrocatheterReverse Medical Corporation · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K914067	Retrieval Device	Target Therapeutics	1991	—
−1	K014109	IN-Time Retrieval Device	Boston Scientific, Target	2002	—
0 (this device)	K091563	Recruit Microcatheter	Reverse Medical Corporation	2009	—

FIG. 1 — Lineage of K091563, 1991–2009Source: 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 MMX? 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 MMX device

#1 K242776 LimFlow V-Ceiverscore 11.0 · 8 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
*	K014109	IN-Time Retrieval Device Summary page 1 …TBD Classification name Percutaneous Retrieval Device Classification regulation 870.5150 MMX Predicate devices K014109; In-Time Retrieval Device; Clearance date: March 12, 2002 Description The Reverse Medical ReCruitT m Microca…	Boston Scientific, Target	2002	—

Also cleared against K014109: 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 18 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K014109.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MMX

1in 2025

2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMX

151in 2022

2007high 151 (2022)2026

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

Recalls per year · MMX

No recall names MMX since 2007.

Adverse event reports per year · MMX

49in 2025

2007high 49 (2025) · low 2 (2007)2025

MAUDE reports naming product code MMX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	2
2008	0	—	6
2009	2	—	6
2010	1	—	11
2011	1	—	15
2012	1	—	13
2013	0	—	10
2014	2	—	11
2015	2	—	5
2016	2	—	16
2017	2	—	29
2018	1	—	15
2019	1	—	17
2020	2	—	14
2021	1	—	22
2022	3	151	37
2023	2	—	40
2024	1	—	32
2025	1	—	49
2026	0	—	—

What is it indicated for?

The Reverse Medical ReCruit TM Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091563 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091563: Recruit Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091563

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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