510(k) · Decided
DecidedRinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerberos Proximal Solutions, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 26, 2004 as substantially equivalent to K031485 (Kerberos Proximal Solutions, 2003) and 7 other predicates after a 118-day review. Its family tree reaches back 4 generations to 1996. 17 later devices descend from it.
- Decided
- Aug 26, 2004
- Review
- 118 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K960806 (1996). 30 ancestors in all, the oldest K873004 (1987). 17 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 3 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 2 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 1 generation backK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
- This deviceK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
- Descendant · cites it directly · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- Descendant · 2 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · 2 generations on · 3 of its ownK120508 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · cites it directly16descendants
- K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 2 generations on9descendants
- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 2 generations on6descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 3 generations on5descendants
- K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −3 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −2 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −1 | K032494 | PVS 1700 Steerable Delivery System Microcatheter | Precision Vascular Systems, Inc. | 2003 | — |
| 0 (this device) | K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 | Kerberos Proximal Solutions, Inc. | 2004 | — |
| +1 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| +2 | K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006 | — |
| +2 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| +3 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +2 | K120508 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031485 | Rinspiration SystemSummary page 1…ubstantially equivalent in intended use and/or method of operation to the following cleared devices. (1) Kerberos Proximal Solutions Rinspiration System (Peripheral) K031485 (2) Cordis Neurovascular, Inc., PROWLER® SELECT 10 and 14 Infusion Catheters K020680 (3) Precision Vascular, PVS 170… | 2003 |
| * | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsSummary page 1…ices. (1) Kerberos Proximal Solutions Rinspiration System (Peripheral) K031485 (2) Cordis Neurovascular, Inc., PROWLER® SELECT 10 and 14 Infusion Catheters K020680 (3) Precision Vascular, PVS 1700 Steerable Delivery System--10 K032494 (4) Micro Therapeutics, Inc., TruLineTM Reinforced V… | 2002 |
| * | K032494 | PVS 1700 Steerable Delivery System MicrocatheterSummary page 1…K031485 (2) Cordis Neurovascular, Inc., PROWLER® SELECT 10 and 14 Infusion Catheters K020680 (3) Precision Vascular, PVS 1700 Steerable Delivery System--10 K032494 (4) Micro Therapeutics, Inc., TruLineTM Reinforced Valved Infusion Catheter K021139 (5) eMed Corp., Microfuse Membrane Infu… | 2003 |
| * | K021139 | Truline Reinforced Valved Infusion CatheterSummary page 1…s K020680 (3) Precision Vascular, PVS 1700 Steerable Delivery System--10 K032494 (4) Micro Therapeutics, Inc., TruLineTM Reinforced Valved Infusion Catheter K021139 (5) eMed Corp., Microfuse Membrane Infusion Catheter K971619 (6) Vascular Solutions, Inc., PRONTO Extraction Catheter K0327… | 2002 |
| * | K971619 | Microfuse Membrane Infusion CatheterSummary page 1…elivery System--10 K032494 (4) Micro Therapeutics, Inc., TruLineTM Reinforced Valved Infusion Catheter K021139 (5) eMed Corp., Microfuse Membrane Infusion Catheter K971619 (6) Vascular Solutions, Inc., PRONTO Extraction Catheter K032763 (7) Lucas Medical, Inc., LMI Irrigation Catheter K972623 (… | 1998 |
| * | K032763 | Vascular Solutions Pronto Extraction CatheterSummary page 1…M Reinforced Valved Infusion Catheter K021139 (5) eMed Corp., Microfuse Membrane Infusion Catheter K971619 (6) Vascular Solutions, Inc., PRONTO Extraction Catheter K032763 (7) Lucas Medical, Inc., LMI Irrigation Catheter K972623 (8) Atrium Medical Corporation, Atrium Clearway PTFE Balloon Cathe… | 2003 |
| * | K972623 | Lmi Irrigation Catheter (Igr)Summary page 1…rp., Microfuse Membrane Infusion Catheter K971619 (6) Vascular Solutions, Inc., PRONTO Extraction Catheter K032763 (7) Lucas Medical, Inc., LMI Irrigation Catheter K972623 (8) Atrium Medical Corporation, Atrium Clearway PTFE Balloon Catheter K020634 Intended Use The Kerberos Proximal Solutions Ri… | 1997 |
| * | K020634 | Modification to Atrium Medical Corporation Clearway Ptfe Balloon CatheterSummary page 1…, PRONTO Extraction Catheter K032763 (7) Lucas Medical, Inc., LMI Irrigation Catheter K972623 (8) Atrium Medical Corporation, Atrium Clearway PTFE Balloon Catheter K020634 Intended Use The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in… | 2002 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050130 | Kerberos Proximal Solutions Rispiration System | 2005 | 16 |
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 8 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 30 ancestors have a recall of any class.
- Of its descendants, K050130 (Kerberos Proximal Solutions, Inc., 2005) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K031485.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in the coronary and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041123
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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