510(k) · Cleared
ClearedMediGuide Technology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQK Computer, Diagnostic, Programmable
Cleared on Dec 13, 2016 as substantially equivalent to K120301 (St. Jude Medical, Mediguide Navigation Systems, 2012) after an 82-day review. Its family tree reaches back 2 generations to 2010. 5 of the 14 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Dec 13, 2016
- Review
- 82 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K102905 (2010). 11 later devices descend from it, 2 citing it directly. 5 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK102905 Guided Medical Positioning System II (GMPS II)Mediguide, Ltd. · 2010
- 1 generation backK120301 Mediguide TechnologySt. Jude Medical, Mediguide Navigation Systems · 2012
- This deviceK162643 MediGuide Technology SystemSt Jude Medical · 2016
- Descendant · cites it directly · 6 of its ownK190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse…Centerline Biomedical, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK230309 Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve…Centerline Biomedical, Inc. · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK242133 Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK241243 Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK201081 AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…cites it directly · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…2 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…2 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…2 generations on · 2023
Most influential descendants
Showing 5 of 11 · See all- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc. · 2019 · cites it directly6descendants
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc. · 2023 · 2 generations on5descendants
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc. · 2024 · 2 generations on3descendants
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc. · 2024 · 2 generations on3descendants
- K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K102905 | Guided Medical Positioning System II (GMPS II) | Mediguide, Ltd. | 2010 | — |
| −1 | K120301 | Mediguide Technology | St. Jude Medical, Mediguide Navigation Systems | 2012 | — |
| 0 (this device) | K162643 | MediGuide Technology System | St Jude Medical | 2016 | — |
| +1 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve… | Centerline Biomedical, Inc. | 2019 | Class I |
| +2 | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter… | Centerline Biomedical, Inc. | 2023 | Class I |
| +2 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)… | Centerline Biomedical, Inc. | 2024 | Class I |
| +2 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… | Centerline Biomedical, Inc. | 2024 | Class I |
| +1 | K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | Philips Medical System Nederland B.V. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 3 | 2 |
| 2025 | 2 | 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.
5 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? (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 |
|---|---|---|---|
| * | K120301 | Mediguide TechnologySummary page 4…Diagnostic Computer Classification Name: 870.1425, computer, diagnostic, programmable Product Code: DQK Class: Class II Predicate Device: K120301-MediGuide™ Technology System Reference K160335 – Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™ Application… | 2012 |
| † | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12… | 2016 |
| † | K160210 | EnSite Precision Cardiac Mapping System v2.0 | 2016 |
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? (5 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.
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · Cites it directly · ◆ 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 · 2 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 · 2 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 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 2 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190106 (Centerline Biomedical, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K120301.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™/Sensor Enabled™ (equipped with a magnetic sensor) 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/K162643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162643: MediGuide Technology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162643
Report an extraction error
Are you the manufacturer?
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