510(k) · Cleared
ClearedHealthview Ecg Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumedx · DQK Computer, Diagnostic, Programmable
Cleared on Dec 20, 2012 as substantially equivalent to K052883 (Datrix, 2005) and 1 other predicate after a 41-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Dec 20, 2012
- Review
- 41 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K842308 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 5 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 4 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 3 generations backK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 2 generations backK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled
- 1 generation backK083639 Muse Cardiology Information System with VmwareGe Medical Systems Information Technologies · 2009 · Recalled
- This deviceK123466 Healthview Ecg ManagerLumedx · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −5 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −4 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −3 | K050614 | Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2005 | 1 |
| −2 | K072502 | Modification to: Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2007 | 2 |
| −1 | K083639 | Muse Cardiology Information System with Vmware | Ge Medical Systems Information Technologies | 2009 | 1 |
| 0 (this device) | K123466 | Healthview Ecg Manager | Lumedx | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 DQK? 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? (2)
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 |
|---|---|---|---|
| * | K052883 | CardioserverSummary page 1…on, is substantially equivalent to bath of the following commercially available devices: 510(k) # Trade Name Manufacturer K052883 Cardio Server Epiphany K(083639 MUSE GE Healthcare… | 2005 |
| * | K083639 | Muse Cardiology Information System with VmwareSummary page 1…commercially available devices: 510(k) # Trade Name Manufacturer K052883 Cardio Server Epiphany K(083639 MUSE GE Healthcare Device description Health View ECG Manager (v… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K052883.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Health View ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical. documents through the use of on-screen measurement and editing tools. The system receives fies (such as ECG, stress, or Hotter) from any compatible device, displaying such data to the clinician for analysis and review.
The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123466: Healthview Ecg Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123466
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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