510(k) · Cleared
ClearedGuided Medical Positioning System (GMPS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediguide, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Oct 16, 2009 as substantially equivalent to K083745 (Paieon, Inc., 2009) and 2 other predicates after a 121-day review. Its family tree reaches back 11 generations to 1993. 6 of the 84 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Oct 16, 2009
- Review
- 121 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K926514 (1993). 72 ancestors in all, the oldest K882061 (1988). 11 later devices descend from it, 2 citing it directly. 6 of the 84 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 7 generations between
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- Descendant · cites it directly · 8 of its ownK120298 CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- Descendant · 2 generations on · 6 of its ownK190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse…Centerline Biomedical, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK230309 Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve…Centerline Biomedical, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK242133 Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK241243 Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
Show all 11 generations
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 10 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 9 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 8 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 7 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 6 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 5 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 4 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…9 generations back · 2003
- K190106 Intra-Operative Positioning System; Simple Curve…2 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…3 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…3 generations on · 2024
Most influential descendants
Showing 5 of 11 · See all- K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012 · cites it directly8descendants
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc. · 2019 · 2 generations on6descendants
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc. · 2023 · 3 generations on5descendants
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc. · 2024 · 3 generations on3descendants
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −10 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −9 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −8 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −7 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −6 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −5 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −4 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −3 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −1 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| 0 (this device) | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
| +1 | K120298 | CPS Excel Mediguide Enabled Guidewire | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | — |
| +2 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve… | Centerline Biomedical, Inc. | 2019 | Class I |
| +3 | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter… | Centerline Biomedical, Inc. | 2023 | Class I |
| +3 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)… | Centerline Biomedical, Inc. | 2024 | Class I |
| +3 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… | Centerline Biomedical, Inc. | 2024 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 1 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 1 |
| 2023 | 1 | 1 |
| 2024 | 2 | 2 |
| 2025 | 1 | 1 |
| 2026 | 2 | 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.
6 devices in this family have a Class I recall. 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K083745 | The IC-Pro System, Model Version 3.2Summary page 2…Cardiovascular 5.10 Predicate Devices: * The IC-PRO System, model version 3.2 [Paieon, Inc.] cleared under K083745. * CARTO XP EP Navigation System, Version 9 [Biosense Webster, Inc.] cleared under K07… | 2009 |
| * | K070240 | Carto XP EP Navigation System, Version 9Summary page 2…eared under K083745. * CARTO XP EP Navigation System, Version 9 [Biosense Webster, Inc.] cleared under K070240; hereinafter: CARTO System. * Niobe Magnetic Navigation System w/Navigant Navigation Workstation… | 2007 |
| * | K060967 | Niobe Magnetic Navigation System W/Navigant WorkstationSummary page 2…reinafter: CARTO System. * Niobe Magnetic Navigation System w/Navigant Navigation Workstation [Stereotaxis Inc.] cleared under K060967; hereinafter: Niobe System. 5.11 Intended Use / Indication for Use: The Guided Medical Positioning Syst… | 2006 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 17 of the 72 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120298 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2012) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K083745.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The Guided Medical Positioning System (gMPS TM ) is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a gMPS TM enabled (equipped with a gMPS TM sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091781: Guided Medical Positioning System (GMPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091781
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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