510(k) · Cleared

Cleared

Renegade HI-Flo Fathom Kit Model M001182XXX

K100892510(k) SpecialCleared Apr 12, 201012-day reviewClass II21 CFR 870.1210

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

Boston Scientific Corp · KRA Catheter, Continuous Flush

Cleared on Apr 12, 2010 as substantially equivalent to K000177 (Boston Scientific Corp, 2000) after a 12-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided: Apr 12, 2010
Review: 12 days
Class: Class II
Product code: KRA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000177 (2000). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000 · Recalled
This deviceK100892 Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp · 2010
Descendant · cites it directly · 5 of its ownK132947 Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp · 2013
Descendant · 2 generations on · 4 of its ownK142259 Direxion Torqueable MicrocatheterBoston Scientific Corp · 2014
Descendant · 3 generations on · 3 of its ownK163701 Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation · 2017 · Recalled
Descendant · 4 generations on · 1 of its ownK201792 TRUSELECT MicrocatheterBoston Scientific Corporation · 2020
Descendant · 5 generations on · 0 of its ownK260771 TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all

K132947Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp · 2013 · cites it directly5descendants
K142259Direxion Torqueable MicrocatheterBoston Scientific Corp · 2014 · 2 generations on4descendants
K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation · 2017 · 3 generations on3descendants
K201792TRUSELECT MicrocatheterBoston Scientific Corporation · 2020 · 4 generations on1descendant
K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000177	Renegade HI-Flo Microcatheter	Boston Scientific Corp	2000	5
0 (this device)	K100892	Renegade HI-Flo Fathom Kit Model M001182XXX	Boston Scientific Corp	2010	—
+1	K132947	Direxion and Direxion HI-Flo Torqueable Microcatheters	Boston Scientific Corp	2013	—
+2	K142259	Direxion Torqueable Microcatheter	Boston Scientific Corp	2014	—
+3	K163701	Direxion and Direxion HI-FLO Torqueable Microcatheters	Boston Scientific Corporation	2017	41
+4	K201792	TRUSELECT Microcatheter	Boston Scientific Corporation	2020	—
+5	K260771	TruSelect™ 2.6 Microcatheter	Boston Scientific Corporation	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	2	0
2017	1	0
2020	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K100892, 2000–2026Source: 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 KRA? 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 KRA device

#1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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
*	K000177	Renegade HI-Flo Microcatheter Summary page 1 …ter kit Classification Catheter, continuous flush Name (21 CFR Part 870.1210, Product Code KRA) Predicate Device Boston Scientific K000177 SE: 7 April 2000 Renegade Hi-Flo Microcatheter Kit Device The R…	Boston Scientific Corp	2000	5

Also cleared against K000177: 7 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132947	Direxion and Direxion HI-Flo Torqueable Microcatheters	Boston Scientific Corp	2013	5
K140329	Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom Kit	Boston Scientific	2014	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?

Its one ancestor has a recall.
Of its descendants, K132947 (Boston Scientific Corp, 2013) has gone furthest, with 5 descendants of its own.
7 other devices also cite its predicate K000177.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KRA

1in 2025

2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007high 268 (2026) · low 29 (2012)2026

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

Recalls per year · KRA

41so far in 2026, the most since 2007

2007high 41 (2026) · low 0 (2017)2026

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

Adverse event reports per year · KRA

980in 2025

2007high 980 (2025) · low 117 (2008)2025

MAUDE reports naming product code KRA, 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	5	44	2	118
2008	7	144	6	117
2009	5	69	8	187
2010	2	—	26	355
2011	2	—	3	239
2012	3	29	3	217
2013	3	126	2	209
2014	4	61	3 (2)	276
2015	0	—	1	339
2016	8	122	3 (1)	418
2017	4	166	0	538
2018	4	178	0	434
2019	4	133	4 (4)	418
2020	6	29	1	381
2021	6	108	0	440
2022	6	228	0	543
2023	7	63	2	829
2024	0	—	0	942
2025	1	—	0	980
2026	5	268	41	—

What is it indicated for?

The Renegade Hi-Flo Fathom Kit is intended for peripheral vascular use. The Fathom guidewire can be used to selectively introduce and position the Renegade Hi-Flo microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100892 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100892: Renegade HI-Flo Fathom Kit Model M001182XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100892

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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