510(k) Report

510(k) · Cleared

Cleared

XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)

K231821510(k) TraditionalCleared Nov 29, 2023161-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

Transit Scientific, LLC · KRA Catheter, Continuous Flush

Cleared on Nov 29, 2023 as substantially equivalent to K163701 (Boston Scientific Corporation, 2017) after a 161-day review. Its family tree reaches back 5 generations to 2000.

Decided
Nov 29, 2023
Review
161 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K000177 (2000). No later device cites it as a predicate yet.

K000177 · Renegade HI-Flo Microcatheter · Boston Scientific Corp · 2000 · recalledK100892 · Renegade HI-Flo Fathom Kit Model M001182XXX · Boston Scientific Corp · 2010K132947 · Direxion and Direxion HI-Flo Torqueable Microcatheters · Boston Scientific Corp · 2013K142259 · Direxion Torqueable Microcatheter · Boston Scientific Corp · 2014K163701 · Direxion and Direxion HI-FLO Torqueable Microcatheters · Boston Scientific Corporation · 2017 · recalled200020052010201520202025
K163701 · Direxion and Direxion HI-FLO Torqueable Microcatheters · Boston Scientific Corporation · 2017 · recalledK142259 · Direxion Torqueable Microcatheter · Boston Scientific Corp · 2014K132947 · Direxion and Direxion HI-Flo Torqueable Microcatheters · Boston Scientific Corp · 2013K100892 · Renegade HI-Flo Fathom Kit Model M001182XXX · Boston Scientific Corp · 2010K000177 · Renegade HI-Flo Microcatheter · Boston Scientific Corp · 2000 · recalled−50
  1. Root · 5 generations backK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000 · Recalled
  2. 4 generations backK100892 Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp · 2010
  3. 3 generations backK132947 Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp · 2013
  4. 2 generations backK142259 Direxion Torqueable MicrocatheterBoston Scientific Corp · 2014
  5. 1 generation backK163701 Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation · 2017 · Recalled
  6. This deviceK231821 XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S…Transit Scientific, LLC · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K000177Renegade HI-Flo MicrocatheterBoston Scientific Corp20005
−4K100892Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp2010—
−3K132947Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp2013—
−2K142259Direxion Torqueable MicrocatheterBoston Scientific Corp2014—
−1K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation201741
0 (this device)K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S…Transit Scientific, LLC2023—
FIG. 1 — Lineage of K231821, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K163701Direxion and Direxion HI-FLO Torqueable Microcatheters
Summary page 5
…inuous Flush Catheter 21 CFR §870.1210, Product Code KRA Device Class: Class II Predicate Device: 510(k) No.: K163701 Model: Direxion and Direxion Hi-Flo Torqueable Microcatheter Manufact…
Boston Scientific Corporation201741

Also cleared against K163701: 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 23 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 1 other device also cites its predicate K163701.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · KRA

1in 2025

2007: 52008: 72009: 52010: 22011: 22012: 32013: 32014: 42016: 82017: 42018: 42019: 42020: 62021: 62022: 62023: 72025: 12026 (partial year): 5
2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007: 44 days median2008: 144 days median2009: 69 days median2012: 29 days median2013: 126 days median2014: 61 days median2016: 122 days median2017: 166 days median2018: 178 days median2019: 133 days median2020: 29 days median2021: 108 days median2022: 228 days median2023: 63 days median2026 (partial year): 268 days median
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

2007: 22008: 62009: 82010: 262011: 32012: 32013: 22014: 3, 2 Class I2015: 12016: 3, 1 Class I2019: 4, 4 Class I2020: 12023: 22026 (partial year): 41
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

2007: 1182008: 1172009: 1872010: 3552011: 2392012: 2172013: 2092014: 2762015: 3392016: 4182017: 5382018: 4342019: 4182020: 3812021: 4402022: 5432023: 8292024: 9422025: 980
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075442118
200871446117
20095698187
20102—26355
20112—3239
20123293217
201331262209
20144613 (2)276
20150—1339
201681223 (1)418
201741660538
201841780434
201941334 (4)418
20206291381
202161080440
202262280543
20237632829
20240—0942
20251—0980
2026526841—

What is it indicated for?

The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

Indications for use as stated in the FDA summary.

Also cleared against K163701

1 other device cites the same predicate.

  • K201792TRUSELECT MicrocatheterBoston Scientific Corporation · 2020

More from Transit Scientific, LLC

5 FDA decisions under this applicant name. See the company

  • K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC · 2024
  • K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC · 2022
  • K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC · 2022
  • K210322XO Cross Support CatheterTransit Scientific, LLC · 2021

Recent decisions in KRA

The KRA category page

  • K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
  • K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
  • K261610Verge™ MicrocatheterInstylla, Inc. · 2026
  • K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
  • K250794InVera Infusion DeviceInvera Medical · 2026

https://510kreport.com/device/K231821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231821: XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231821

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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