510(k) Report

510(k) · Cleared

Cleared

Kerberos Occluding Guide Catheter and Accessories

K041151510(k) TraditionalCleared Jul 22, 200480-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

Kerberos Proximal Solutions, Inc. · DQY Catheter, Percutaneous

Cleared on Jul 22, 2004 as substantially equivalent to K021899 (Concentric Medical, Inc., 2002) and 4 other predicates after an 80-day review. Its family tree reaches back 2 generations to 2001. 25 later devices descend from it.

Decided
Jul 22, 2004
Review
80 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K010954 (2001). 7 ancestors in all, the oldest K973298 (1998). 25 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1998: 1 other ancestor2009: 1 descendant cleared2010: 1 descendant cleared2011: 2 descendants cleared2012: 5 descendants cleared2014: 2 descendants cleared2020: 2 descendants cleared2015: 2 descendants cleared2016: 4 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2017: 2 descendants cleared2026: 1 descendant clearedK010954 · Concentric Balloon Guide Catheter, Model 90031 · Concentric Medical, Inc. · 2001 · recalledK021899 · Concentric Balloon Guide Catheter, Model 90072 · Concentric Medical, Inc. · 2002 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 2 descendants6 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 deviceK041151 Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004
  4. Descendant · cites it directly · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
  5. Descendant · 2 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
  6. Descendant · 2 generations on · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
  7. Descendant · 2 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
  8. Descendant · 2 generations on · 7 of its ownK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 22012: 52014: 22015: 22016: 42017: 22019: 12020: 22023: 22026: 1
2009high 5 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 25 · See all
  • K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · cites it directly24descendants
  • K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 2 generations on14descendants
  • K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · 2 generations on11descendants
  • K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 2 generations on8descendants
  • K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011 · 2 generations on7descendants
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)K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.2004—
+1K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical20091
+2K101591Stingray Orienting Balloon CatheterBridgepoint Medical20101
+2K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…Bridge Medical, Inc.20111
+2K121763Multicross Support CatheterRoxwood Medical, Inc.2012—
+2K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200120
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201120
201250
201420
201520
201640
201720
201910
202020
202320
202610
FIG. 1 — Lineage of K041151, 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? (5)

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
*K021899Concentric Balloon Guide Catheter, Model 90072
Summary page 1
…g Guide Catheter (OGC) and Accessories is substantially equivalent in intended use and method of operation to a combination of the following predicate devices: 1) K021899 - Concentric Medical, Inc.; Balloon Guide Catheter 2) K002286 - Cook Inc.; LDOB Occlusion Balloon Catheter 3) K0334…
Concentric Medical, Inc.20021
*K002286Ldob Occlusion Balloon Catheter
Summary page 1
…intended use and method of operation to a combination of the following predicate devices: 1) K021899 - Concentric Medical, Inc.; Balloon Guide Catheter 2) K002286 - Cook Inc.; LDOB Occlusion Balloon Catheter 3) K033441 - Boston Scientific Corporation; 6F RunWay Guide Catheter 4…
Cook, Inc.2001—
*K033441Boston Scientific 6F Runway Guide Catheter
Summary page 1
…ollowing predicate devices: 1) K021899 - Concentric Medical, Inc.; Balloon Guide Catheter 2) K002286 - Cook Inc.; LDOB Occlusion Balloon Catheter 3) K033441 - Boston Scientific Corporation; 6F RunWay Guide Catheter 4) K984214 - Cordis; Commodore Temporary Occlusion Balloon Cathe…
Boston Scientific Corp20032
*K984214Cordis Endovascular Temporary Occlusion Balloon Catheter
Summary page 1
…lloon Guide Catheter 2) K002286 - Cook Inc.; LDOB Occlusion Balloon Catheter 3) K033441 - Boston Scientific Corporation; 6F RunWay Guide Catheter 4) K984214 - Cordis; Commodore Temporary Occlusion Balloon Catheter 5) K973298 - Cardima; Vueport Balloon OGC Kerberos Proximal S…
Cordis Neurovascular, Inc.1999—
*K973298Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter
Summary page 1
…Catheter 3) K033441 - Boston Scientific Corporation; 6F RunWay Guide Catheter 4) K984214 - Cordis; Commodore Temporary Occlusion Balloon Catheter 5) K973298 - Cardima; Vueport Balloon OGC Kerberos Proximal Solutions, Inc. Occluding Guide Catheter 510(k) Submission. 04/28/04 Page 5…
Cardima, Inc.1998—

Also cleared against K021899: 4 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical200924

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 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
  • 4 of the 7 ancestors have a recall of any class.
  • Of its descendants, K080987 (Bridgepoint Medical, 2009) has gone furthest, with 24 descendants of its own.
  • 4 other devices also cite its predicate K021899.

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 Kerberos Proximal Solutions Occluding Guide Catheter (OCG) and Accessories are intended to facilitate the use and guidance of intravascular catheters into selected blood vessels in the peripheral, cardiovascular and neurovascular systems. The balloon provides temporary vascular occlusion during these percutaneous procedures.

Indications for use as stated in the FDA summary.

Also cleared against K021899

4 other devices cite the same predicate.

  • K120781Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM LengthFuji Systems Corp. · 2012
  • K112262Reflex Ballon Guide CatheterReverse Medical Corporation · 2011
  • K102657Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
  • K053491Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006

More from Kerberos Proximal Solutions, Inc.

5 FDA decisions under this applicant name. See the company

  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004
  • K041291Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004

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/K041151 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041151: Kerberos Occluding Guide Catheter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041151

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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