510(k) Report

510(k) · Cleared

Cleared

Asahi Precious Guide Catheter

K061601510(k) TraditionalCleared Nov 17, 2006162-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

Asahi Intecc Co., Ltd. · DQY Catheter, Percutaneous

Cleared on Nov 17, 2006 as substantially equivalent to K020028 (Boston Scientific, 2002) and 1 other predicate after a 162-day review. Its family tree reaches back 2 generations to 2001. 109 later devices descend from it.

Decided
Nov 17, 2006
Review
162 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K010874 (2001). 109 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 3 descendants cleared2007: 1 descendant cleared2013: 6 descendants cleared2012: 4 descendants cleared2015: 5 descendants cleared2011: 3 descendants cleared2014: 5 descendants cleared2016: 7 descendants cleared2017: 8 descendants cleared2021: 4 descendants cleared2018: 8 descendants cleared2023: 10 descendants cleared2020: 5 descendants cleared2022: 8 descendants cleared2019: 6 descendants cleared2025: 13 descendants cleared2026: 6 descendants cleared2024: 7 descendants clearedK010874 · 6F Mach 1, Model 34356-XXX · Boston Scientific Corp · 2001 · recalledK020028 · 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX · Boston Scientific · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 14 descendants3 generations forward: 14 descendants4 generations forward: 22 descendants5 generations forward: 18 descendants6 generations forward: 13 descendants7 generations forward: 7 descendants8 generations forward: 7 descendants9 generations forward: 5 descendants10 generations forward: 6 descendants K020028 · 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX · Boston Scientific · 2002 · recalledK010874 · 6F Mach 1, Model 34356-XXX · Boston Scientific Corp · 2001 · recalled0+5+10
  1. Root · 2 generations backK010874 6F Mach 1, Model 34356-XXXBoston Scientific Corp · 2001 · Recalled
  2. 1 generation backK020028 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F…Boston Scientific · 2002 · Recalled
  3. This deviceK061601 Asahi Precious Guide CatheterAsahi Intecc Co., Ltd. · 2006
  4. Descendant · cites it directly · 105 of its ownK093268 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · Recalled
  5. Descendant · 2 generations on · 103 of its ownK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
  6. Descendant · 2 generations on · 90 of its ownK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  7. Descendant · 3 generations on · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  8. Descendant · 2 generations on · 81 of its ownK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012

Showing 5 of 109 descendants. See all descendants

Descendants cleared per year

2007: 12010: 32011: 32012: 42013: 62014: 52015: 52016: 72017: 82018: 82019: 62020: 52021: 42022: 82023: 102024: 72025: 132026: 6
2007high 13 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 109 · See all
  • K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly105descendants
  • K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH · 2010 · 2 generations on103descendants
  • K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on90descendants
  • K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 3 generations on84descendants
  • K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012 · 2 generations on81descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K0108746F Mach 1, Model 34356-XXXBoston Scientific Corp200111
−1K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXXBoston Scientific200211
0 (this device)K061601Asahi Precious Guide CatheterAsahi Intecc Co., Ltd.2006—
+1K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20102
+2K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizin Systeme Boblingen GmbH2010—
+2K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112
+3K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20111
+2K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201030
201130
201240
201360
201450
201550
201670
201780
201880
201960
202050
202140
202280
2023100
202470
2025130
202660
FIG. 1 — Lineage of K061601, 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? (2)

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
*K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
Summary page 1
…Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Boston Scientific MACH 1 (Various models) (K020028) Boston Scientific 6F MACH 1 (K010874) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The AS…
Boston Scientific200211
*K0108746F Mach 1, Model 34356-XXX
Summary page 1
…CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Boston Scientific MACH 1 (Various models) (K020028) Boston Scientific 6F MACH 1 (K010874) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The ASAHI Precious guide catheter is intended for use in coronary a…
Boston Scientific Corp200111

Also cleared against K020028: 2 other devices →

What descends from it? (109)

See all 109

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

NumberDeviceApplicantDecidedDescendants
K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010105
K091188Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd.20101
K072316Precious Plus Guide CatheterAsahi Intecc Co., Ltd.20070

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 5 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K093268 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) has gone furthest, with 105 descendants of its own.
  • 2 other devices also cite its predicate K020028.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 ASAHI Precious guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K020028

2 other devices cite the same predicate.

  • K091188Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd. · 2010
  • K0712268FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043Spectranetics Corp. · 20072 recalls

More from Asahi Intecc Co., Ltd.

84 FDA decisions under this applicant name. See the company

  • K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
  • K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd. · 2026
  • K251560FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025
  • K251240Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2025
  • K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd. · 2025

Recent decisions in DQY

The DQY category page

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https://510kreport.com/device/K061601 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061601: Asahi Precious Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061601

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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