510(k) · Decided
DecidedRinspiration Catheter System, Models 50135, 550135, P7065, P70135
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerberos Proximal Solutions, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Sep 20, 2006 as substantially equivalent to K050130 (Kerberos Proximal Solutions, Inc., 2005) after a 44-day review. Its family tree reaches back 6 generations to 1990. 9 later devices descend from it.
- Decided
- Sep 20, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904788 (1990). 39 ancestors in all, the oldest K873004 (1987). 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 5 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 4 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 3 generations backK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
- 2 generations backK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
- 1 generation backK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- This deviceK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
- Descendant · 4 generations on · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · cites it directly6descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 2 generations on5descendants
- K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · 3 generations on1descendant
- K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology · 2020 · 3 generations on1descendant
- K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −5 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −4 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −3 | K031485 | Rinspiration System | Kerberos Proximal Solutions | 2003 | — |
| −2 | K041291 | Rinspiration System | Kerberos Proximal Solutions, Inc. | 2004 | — |
| −1 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| 0 (this device) | K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006 | — |
| +1 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| +2 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +3 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +3 | K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical… | Control Medical Technology | 2020 | — |
| +4 | K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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 QEZ? 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050130 | Kerberos Proximal Solutions Rispiration SystemSummary page 5…Code Embolectomy Catheter Il 870.5150 DXE Predicate Device Name: Rinspiration System Manufacturer: Kerberos Proximal Solutions, Inc. Status: Post-enactment 510(k) # K050130 Indications for Use The Indications for Use for the Rinspiration Catheter System remains identical to the cleared device indic… | 2005 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 39 ancestors have a recall of any class.
- Of its descendants, K080901 (Lumen Biomedical, Inc., 2008) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K050130.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The Kerberos Proximal Solutions Rinspiration Catheter System is intended to infuse physician specified fluid and remove/aspirate fresh, soft emboli and thrombi from the coronary and peripheral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062275
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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