510(k) · Cleared
ClearedIOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centerline Biomedical, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Feb 17, 2026 as substantially equivalent to K243842 (Centerline Biomedical, Inc., 2025) after a 60-day review. Its family tree reaches back 17 generations to 1993. 6 of the 96 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 17, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K926514 (1993). 95 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 6 of the 96 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 13 generations between
- 3 generations backK230309 Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve…Centerline Biomedical, Inc. · 2023 · Recalled (Class I)
- 2 generations backK241243 Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- 1 generation backK243842 Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · Recalled (Class I)
- This deviceK254089 IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical, Inc. · 2026
Show all 17 generations
- Root · 17 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 16 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 15 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 14 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 13 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 12 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 11 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 10 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 9 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 8 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 7 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 6 generations backK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- 5 generations backK120298 CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- 4 generations backK190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse…Centerline Biomedical, Inc. · 2019 · Recalled (Class I)
- 3 generations backK230309 Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve…Centerline Biomedical, Inc. · 2023 · Recalled (Class I)
- 2 generations backK241243 Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- 1 generation backK243842 Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · Recalled (Class I)
- This deviceK254089 IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical, Inc. · 2026
Class I recalls in this family
- K243842 Intra-Operative Positioning System (IOPS®)direct predicate · 2025
- K242133 Intra-Operative Positioning System (IOPS®)…2 generations back · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…2 generations back · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…2 generations back · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −16 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −15 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −14 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −13 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −12 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −11 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −10 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −9 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −8 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −7 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −6 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
| −5 | K120298 | CPS Excel Mediguide Enabled Guidewire | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | — |
| −4 | 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 |
| −2 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… | Centerline Biomedical, Inc. | 2024 | Class I |
| −1 | K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025 | Class I |
| 0 (this device) | K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm… | Centerline Biomedical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 1 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 1 |
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? (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 |
|---|---|---|---|
| * | K243842 | Intra-Operative Positioning System (IOPS®)Summary page 5…5 II. Predicate Device The predicate device to which substantial equivalence is claimed is the Intra- Operative Positioning System (IOPS), cleared under K243842. III. Device Description The IOPS® Visionary system displays the position and orientation of sensor-equipped IOPS… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 2 generations back · ◆ in the 2024 ancestors 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 back · ◆ on the line of descent in 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 back · ◆ on the line of descent in FIG. 11 Class I recall
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 13 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 23 of the 95 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K243842.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 IOPS Visionary System is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254089: IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254089
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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