510(k) Report

510(k) · Cleared

Cleared

Concentric Balloon Guide Catheter

K102657510(k) TraditionalCleared Nov 17, 201063-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

Concentric Medical, Inc. · DQY Catheter, Percutaneous

Cleared on Nov 17, 2010 as substantially equivalent to K010954 (Concentric Medical, Inc., 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 2001. 48 later devices descend from it.

Decided
Nov 17, 2010
Review
63 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K010954 (2001). 48 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2014: 1 descendant cleared2022: 3 descendants cleared2013: 1 descendant cleared2021: 4 descendants cleared2025: 5 descendants cleared2016: 1 descendant cleared2015: 1 descendant cleared2024: 8 descendants cleared2023: 5 descendants cleared2018: 2 descendants cleared2019: 5 descendants cleared2020: 4 descendants cleared2026: 6 descendants clearedReference device: K070521 · Modified Mercy Retriever, Model 90070 · Concentric Medical, Inc. · 2007Reference device: K082034 · Modification to Merci Retriever · Concentric Medical, Inc. · 2008 · recalledK010954 · Concentric Balloon Guide Catheter, Model 90031 · Concentric Medical, Inc. · 2001 · recalledK021899 · Concentric Balloon Guide Catheter, Model 90072 · Concentric Medical, Inc. · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 13 descendants5 generations forward: 12 descendants6 generations forward: 5 descendants7 generations forward: 6 descendants8 generations forward: 1 descendant K021899 · Concentric Balloon Guide Catheter, Model 90072 · Concentric Medical, Inc. · 2002 · recalledK010954 · Concentric Balloon Guide Catheter, Model 90031 · Concentric Medical, Inc. · 2001 · recalled0+5
  1. Root · 2 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
  2. 1 generation backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
  3. This deviceK102657 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
  4. Descendant · cites it directly · 47 of its ownK112404 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012 · Recalled
  5. Descendant · 2 generations on · 28 of its ownK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
  6. Descendant · 3 generations on · 26 of its ownK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
  7. Descendant · 4 generations on · 19 of its ownK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
  8. Descendant · 2 generations on · 15 of its ownK122581 Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · Recalled

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2012: 22013: 12014: 12015: 12016: 12018: 22019: 52020: 42021: 42022: 32023: 52024: 82025: 52026: 6
2012high 8 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 48 · See all
  • K112404Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012 · cites it directly47descendants
  • K133177Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · 2 generations on28descendants
  • K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker · 2015 · 3 generations on26descendants
  • K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018 · 4 generations on19descendants
  • K122581Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K010954Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc.20011
−1K021899Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc.20021
0 (this device)K102657Concentric Balloon Guide CatheterConcentric Medical, Inc.2010—
+1K112404Concentric Balloon Guide CatheterConcentric Medical, Inc.20121
+2K133177Modified HD Guide CatheterConcentric Medical, Inc.20143
+3K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access…Stryker20153
+4K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2018—
+2K122581Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc.20121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201310
201410
201510
201610
201820
201950
202040
202140
202230
202350
202480
202550
202660
FIG. 1 — Lineage of K102657, 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
*K010954Concentric Balloon Guide Catheter, Model 90031
Summary page 1
…ntact Kirsten Valley Senior Vice President, Technology and Regulatory Affairs Predicate Device Concentric Balloon Guide Catheters (K010954 and K021899). Device Description The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness…
Concentric Medical, Inc.20011
*K021899Concentric Balloon Guide Catheter, Model 90072
Summary page 1
…Kirsten Valley Senior Vice President, Technology and Regulatory Affairs Predicate Device Concentric Balloon Guide Catheters (K010954 and K021899). Device Description The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters de…
Concentric Medical, Inc.20021
†K070521Modified Mercy Retriever, Model 90070Concentric Medical, Inc.2007—
†K082034Modification to Merci RetrieverConcentric Medical, Inc.20081

Also cleared against K010954: 2 other devices →

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K112404Concentric Balloon Guide CatheterConcentric Medical, Inc.201247

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 9 years and passes through 1 company; a new generation was cleared every 8.4 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K112404 (Concentric Medical, Inc., 2012) has gone furthest, with 47 descendants of its own.
  • 2 other devices also cite its predicate K010954.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever.

Indications for use as stated in the FDA summary.

Also cleared against K010954

2 other devices cite the same predicate.

  • K112262Reflex Ballon Guide CatheterReverse Medical Corporation · 2011
  • K021899Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 20021 recall

More from Concentric Medical, Inc.

45 FDA decisions under this applicant name. See the company

  • K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. · 20181 recall
  • DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo…Concentric Medical, Inc. · 2016
  • K150616Trevo XP ProVue Retriever (4x30mm)Concentric Medical, Inc. · 2015
  • K143077Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc. · 20153 recalls
  • K133177Modified HD Guide CatheterConcentric Medical, Inc. · 20143 recalls

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
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  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
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https://510kreport.com/device/K102657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102657: Concentric Balloon Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102657

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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