510(k) · Cleared
ClearedGuided Measurement Catheter (GMC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediguide, Ltd. · DQO Catheter, Intravascular, Diagnostic
Cleared on Oct 16, 2009 as substantially equivalent to K051337 (Volcano Corporation, 2005) and 2 other predicates after a 121-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Oct 16, 2009
- Review
- 121 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K934139 (1995). 12 ancestors in all, the oldest K841802 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 4 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 3 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 2 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 1 generation backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- This deviceK091780 Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK142235 CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled…St Jude Medical · 2014
Most influential descendants
Showing 1 of 1 · See all- K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterSt Jude Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −4 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −3 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −2 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −1 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| 0 (this device) | K091780 | Guided Measurement Catheter (GMC) | Mediguide, Ltd. | 2009 | — |
| +1 | K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner… | St Jude Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model…Summary page 2…Predicate Devices: • Eagle Eye TM Gold IVUS Catheter and Volcano VH IVUS System [Volcano Corp.] cleared under K051337; hereinafter: Eagle Eye Catheter. * Metricath System [Angiometrx Inc.] cleared under K042685.… | 2005 |
| * | K042685 | Metricath SystemSummary page 2…[Volcano Corp.] cleared under K051337; hereinafter: Eagle Eye Catheter. * Metricath System [Angiometrx Inc.] cleared under K042685. - CS RefStar Catheter [Biosense Webster Inc.] cleared under K080425; hereinafter:… | 2004 |
| * | K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Summary page 2…er. * Metricath System [Angiometrx Inc.] cleared under K042685. - CS RefStar Catheter [Biosense Webster Inc.] cleared under K080425; hereinafter: RefStar Catheter. 5.11 Intended Use / Indication for Use: The Guid… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter | 2014 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K142235 (St Jude Medical, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K051337.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 GMCTM device is a gMPSTM enabled intravascular catheter intended for the diagnostic evaluation of the coronary vasculature in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI).
The GMCTM is used with compatible gMPSTM system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking.
The System is indicated for use as an adjunct to fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091780: Guided Measurement Catheter (GMC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091780
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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