510(k) Report

510(k) · Cleared

Recalled · 2009

Renegade HI-Flo Microcatheter

K000177510(k) TraditionalCleared Apr 7, 200078-day reviewClass II21 CFR 870.1210Recalls 5

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 7, 2000 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 72 later devices descend from it. It has been recalled 5 times.

Decided
Apr 7, 2000
Review
78 days
Class
Class II
Product code
KRA
Recalls
5
Predicates
0

72 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2012: 4 descendants cleared2010: 1 descendant cleared2003: 2 descendants cleared2014: 2 descendants cleared2005: 7 descendants cleared2011: 2 descendants cleared2004: 4 descendants cleared2008: 5 descendants cleared2013: 4 descendants cleared2025: 2 descendants cleared2006: 5 descendants cleared2017: 3 descendants cleared2019: 5 descendants cleared2015: 1 descendant cleared2020: 3 descendants cleared2023: 1 descendant cleared2021: 2 descendants cleared2024: 4 descendants cleared2026: 5 descendants cleared2016: 2 descendants cleared2018: 2 descendants cleared2022: 2 descendants cleared200020052010201520202025
  1. This deviceK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000
  2. Descendant · cites it directly · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  3. Descendant · 2 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  4. Descendant · 3 generations on · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004
  5. Descendant · 4 generations on · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
  6. Descendant · 5 generations on · 35 of its ownK051319 Lysus Infusion SystemEkos Corp. · 2005

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2003: 22004: 42005: 72006: 52007: 42008: 52010: 12011: 22012: 42013: 42014: 22015: 12016: 22017: 32018: 22019: 52020: 32021: 22022: 22023: 12024: 42025: 22026: 5
2003high 7 (2005) · low 0 (2009)2026

Most influential descendants

Showing 5 of 72 · See all
  • K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · cites it directly50descendants
  • K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 2 generations on46descendants
  • K041629Lysus Infusion SystemEkos Corp. · 2004 · 3 generations on39descendants
  • K042456Lysus Infusion SystemEkos Corp. · 2004 · 4 generations on38descendants
  • K051319Lysus Infusion SystemEkos Corp. · 2005 · 5 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000177Renegade HI-Flo MicrocatheterBoston Scientific Corp2000—
+1K030637Ekos Peripheral Infusion SystemEkos Corp.2003—
+2K033214Ekos Peripheral Infusion SystemEkos Corp.2003—
+3K041629Lysus Infusion SystemEkos Corp.2004—
+4K042456Lysus Infusion SystemEkos Corp.20043
+5K051319Lysus Infusion SystemEkos Corp.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200440
200570
200650
200740
200850
201010
201120
201240
201340
201420
201510
201620
201730
201820
201950
202030
202120
202220
202310
202440
202520
202650
FIG. 1 — Lineage of K000177, 2000–2026Source: 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), 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 14.5 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (72)

See all 72

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

NumberDeviceApplicantDecidedDescendants
K030637Ekos Peripheral Infusion SystemEkos Corp.200350
K041826Ekos Ultrasound Infusion SystemEkos Corp.200519
K063620Ekos Micro-Infusion SystemEkos Corp.200712
K113778Excelsior XT-27 MicrocatheterStryker Neurovascular20128
K100892Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp20107
K112124MicrocatheterNavilyst Medical, Inc.20112
K140329Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom KitBoston Scientific20140
K112690Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd.20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 26, 2009Not classifiedZ-2245-2009PackagingBoston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.
Aug 26, 2009Not classifiedZ-2244-2009PackagingBoston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.
Aug 24, 2009Not classifiedZ-0357-2011Packaging process controlSterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.
Sep 10, 2007Not classifiedZ-0109-2008Packaging process controlIncorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
Aug 10, 2005Not classifiedZ-0122-2007OtherOuter box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030637 (Ekos Corp., 2003) has gone furthest, with 50 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—

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https://510kreport.com/device/K000177 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000177: Renegade HI-Flo Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000177

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026