510(k) · Cleared
ClearedCardio-View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curlview Igt, LLC · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Nov 26, 2008 as substantially equivalent to K073372 (Systemsone, 2007) after a 15-day review. Its family tree reaches back 6 generations to 1994. 9 later devices descend from it.
- Decided
- Nov 26, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941811 (1994). 22 ancestors in all, the oldest K822695 (1982). 9 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 2 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 1 generation backK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- This deviceK083321 Cardio-ViewCurlview Igt, LLC · 2008
- Descendant · cites it directly · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK112645 Radiforce Large Monitor SystemEizo GmbH · 2011
- Descendant · 2 generations on · 1 of its ownK172969 Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK162571 Bioflux SoftwareBiotricity, Inc. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · cites it directly3descendants
- K122632Guava IICardiocomm Solutions, Inc. · 2014 · 2 generations on2descendants
- K112645Radiforce Large Monitor SystemEizo GmbH · 2011 · cites it directly2descendants
- K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd. · 2018 · 2 generations on1descendant
- K162571Bioflux SoftwareBiotricity, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −5 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −4 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −3 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −2 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −1 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| 0 (this device) | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| +1 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +2 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| +1 | K112645 | Radiforce Large Monitor System | Eizo GmbH | 2011 | — |
| +2 | K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018 | — |
| +3 | K162571 | Bioflux Software | Biotricity, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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.
Planning a device in DXJ? 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 DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 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 |
|---|---|---|---|
| * | K073372 | Electrophysiology Systems Integrator (Epsi)Summary page 1…Product Code: DXJ Equivalent Marketed Electrophysiology Systems Integrator (EPSI) Device(s): SystemsOne, LLC (K073372) Device Description: Cardio-View is a very large screen monitor for integrating the… | 2007 |
What descends from it? (9)
4 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 14 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K111320 (Cardiocomm Solutions, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K073372.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083321: Cardio-View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083321
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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