510(k) Report

510(k) · Cleared

Cleared

Easy Rider Micro Catheter

K974473510(k) TraditionalCleared Jun 17, 1998203-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

Micro Therapeutics, Inc. · KRA Catheter, Continuous Flush

Cleared on Jun 17, 1998 after a 203-day review. The FDA summary names its predicate without a number. 40 later devices descend from it.

Decided
Jun 17, 1998
Review
203 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
0

40 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2003: 4 descendants cleared2012: 4 descendants cleared2009: 2 descendants cleared2002: 1 descendant cleared2006: 2 descendants cleared2004: 4 descendants cleared2005: 2 descendants cleared2021: 1 descendant cleared2020: 3 descendants cleared2015: 2 descendants cleared2019: 1 descendant cleared2017: 2 descendants cleared2025: 2 descendants cleared2008: 2 descendants cleared2007: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2016: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
  2. Descendant · cites it directly · 39 of its ownK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
  3. Descendant · 2 generations on · 20 of its ownK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
  4. Descendant · 3 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  5. Descendant · 4 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  6. Descendant · 5 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12003: 42004: 42005: 22006: 22007: 22008: 22009: 22012: 42014: 12015: 22016: 12017: 22018: 12019: 12020: 32021: 12023: 12025: 22026: 1
2000high 4 (2003) · low 0 (2001)2026

Most influential descendants

Showing 5 of 40 · See all
  • K993672Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000 · cites it directly39descendants
  • K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003 · 2 generations on20descendants
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 3 generations on17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 4 generations on16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974473Easy Rider Micro CatheterMicro Therapeutics, Inc.1998—
+1K993672Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc.2000—
+2K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.2003—
+3K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+4K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+5K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200340
200440
200520
200620
200720
200820
200920
201240
201410
201520
201610
201720
201810
201910
202030
202110
202310
202520
202610
FIG. 1 — Lineage of K974473, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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
*—FasTracker™ -10 Infusion Catheter
Named without a submission number
—
*—RapidTRANSIT™ Infusion Catheters
Named without a submission number
—
*—JetStream™ Infusion Catheter
Named without a submission number
—

What descends from it? (40)

See all 40

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993672Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc.200039

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?

  • Of its descendants, K993672 (Micro Therapeutics, Inc., 2000) has gone furthest, with 39 descendants of its own.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 catheter is intended to be used for the controlied infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Micro Therapeutics, Inc.

51 FDA decisions under this applicant name. See the company

  • K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012
  • K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
  • K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and Syringe Adapter AccessoryMicro Therapeutics, Inc. · 2009
  • K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
  • K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 20082 recalls

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/K974473 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974473: Easy Rider Micro Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974473

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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