510(k) Report

510(k) · Cleared

Cleared

RIST Cath Radial Access Long Sheath

K191551510(k) TraditionalCleared Dec 23, 2019194-day reviewClass II21 CFR 870.1250

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

Rist Neurovascular, Inc. · DQY Catheter, Percutaneous

Cleared on Dec 23, 2019 as substantially equivalent to K152876 (Tni Manufacturing, Inc., 2016) after a 194-day review. Its family tree reaches back 7 generations to 2001. 6 later devices descend from it.

Decided
Dec 23, 2019
Review
194 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K010954 (2001). 9 ancestors in all, the oldest K010853 (2001). 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2001: 1 other ancestor2023: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2026: 2 descendants clearedReference device: K173831 · Glidesheath Slender · Terumo Medical Corporation · 2018 · recalledK010954 · Concentric Balloon Guide Catheter, Model 90031 · Concentric Medical, Inc. · 2001 · recalledK021899 · Concentric Balloon Guide Catheter, Model 90072 · Concentric Medical, Inc. · 2002 · recalledK053491 · Penumbra Balloon Guide Catheter, Model 7.5F · Penumbra, Inc. · 2006K070970 · Neuron Support Catheter System, Model 5F/6F · Penumbra, Inc. · 2007 · recalledK082290 · Neuron Delivery Catheter 070 · Penumbra, Inc. · 2008 · recalledK111380 · Neuron Max System · Penumbra, Inc. · 2011K152876 · Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM · Tni Manufacturing, Inc. · 2016 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants K152876 · Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM · Tni Manufacturing, Inc. · 2016 · recalledK111380 · Neuron Max System · Penumbra, Inc. · 2011K082290 · Neuron Delivery Catheter 070 · Penumbra, Inc. · 2008 · recalledK070970 · Neuron Support Catheter System, Model 5F/6F · Penumbra, Inc. · 2007 · recalledK053491 · Penumbra Balloon Guide Catheter, Model 7.5F · Penumbra, Inc. · 2006K021899 · Concentric Balloon Guide Catheter, Model 90072 · Concentric Medical, Inc. · 2002 · recalledK010954 · Concentric Balloon Guide Catheter, Model 90031 · Concentric Medical, Inc. · 2001 · recalled−50
  1. Root · 7 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
  2. 6 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
  3. 5 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
  4. 4 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
  5. 3 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
  6. 2 generations backK111380 Neuron Max SystemPenumbra, Inc. · 2011
  7. 1 generation backK152876 Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or…Tni Manufacturing, Inc. · 2016 · Recalled
  8. This deviceK191551 RIST Cath Radial Access Long SheathRist Neurovascular, Inc. · 2019
  9. Descendant · cites it directly · 2 of its ownK231393 Radical the Dude 7F Guide CatheterMaduro Medical, Inc. · 2023
  10. Descendant · cites it directly · 2 of its ownK211990 Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
  11. Descendant · cites it directly · 1 of its ownK241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025
  12. Descendant · 2 generations on · 0 of its ownK254178 SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
  13. Descendant · 2 generations on · 0 of its ownK253975 Radical 6F Access CatheterMaduro Medical, Inc. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2021: 12023: 12025: 22026: 2
2021high 2 (2025) · low 0 (2022)2026

Most influential descendants

Showing 5 of 6 · See all
  • K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc. · 2023 · cites it directly2descendants
  • K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · cites it directly2descendants
  • K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025 · cites it directly1descendant
  • K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026 · 2 generations on0descendants
  • K253975Radical 6F Access CatheterMaduro Medical, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K010954Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc.20011
−6K021899Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc.20021
−5K053491Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc.2006—
−4K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc.20071
−3K082290Neuron Delivery Catheter 070Penumbra, Inc.20081
−2K111380Neuron Max SystemPenumbra, Inc.2011—
−1K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc.20161
0 (this device)K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc.2019—
+1K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.2023—
+1K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2021—
+1K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2025—
+2K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.2026—
+2K253975Radical 6F Access CatheterMaduro Medical, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202310
202520
202620
FIG. 1 — Lineage of K191551, 2001–2026Source: 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), 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 DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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
*K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM
Summary page 4
…s: Class II Product Panel: Cardiovascular Product Code: DQY Predicate Device: Stryker AXS Infinity # K 152876 Reference Predicate: Terumo Glidesheath Slender # K173831…
Tni Manufacturing, Inc.20161
†K173831Glidesheath SlenderTerumo Medical Corporation20181

Also cleared against K152876: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.20232
K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212
K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251

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 4 companies; a new generation was cleared every 2.7 years on median.
  • 7 of the 9 ancestors have a recall of any class.
  • Of its descendants, K231393 (Maduro Medical, Inc., 2023) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K152876.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The RIST Cath Radial Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K152876

2 other devices cite the same predicate.

  • K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc. · 2020
  • K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc. · 20171 recall

More from Rist Neurovascular, Inc.

3 FDA decisions under this applicant name. See the company

  • K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
  • K200417RIST Radial Access CatheterRist Neurovascular, Inc. · 2020

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K191551 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191551: RIST Cath Radial Access Long Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191551

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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