510(k) · Cleared
ClearedInfinity Megacare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Sep 9, 2003 as substantially equivalent to K980625 (Siemens Medical Solutions USA, Inc., 1998) and 3 other predicates after a 75-day review. Its family tree reaches back 3 generations to 1984. 14 later devices descend from it.
- Decided
- Sep 9, 2003
- Review
- 75 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K842308 (1984). 9 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 2 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 1 generation backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- This deviceK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- Descendant · cites it directly · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- Descendant · 2 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
- Descendant · 4 generations on · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · cites it directly13descendants
- K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · cites it directly8descendants
- K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 2 generations on7descendants
- K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014 · 3 generations on6descendants
- K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −2 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −1 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| 0 (this device) | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| +1 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| +2 | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | 2 |
| +3 | K133534 | Mckesson Cardiology Ecg Mobile | Mckesson Israel, Ltd. | 2014 | — |
| +4 | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K980625 | Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg)Summary page 1…LOS Computer, diagnostic, programmable DQK I1 21CFR 870.1425 Predicate Device Identification: K980625 Infinity MultiView Workstation Enhanced with Diagnostic Statements (Rest… | 1998 |
| * | K992637 | Muse Cardiovascular Information SystemSummary page 1…ification: K980625 Infinity MultiView Workstation Enhanced with Diagnostic Statements (Rest ECG) K992637 Muse Cardiovascular Information System K974420 TraceMaster ECG Management System… | 1999 |
| * | K974420 | M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit StationSummary page 1…ion Enhanced with Diagnostic Statements (Rest ECG) K992637 Muse Cardiovascular Information System K974420 TraceMaster ECG Management System K946281 Burdick Eclipse 4 Electrocardiograph De… | 1998 |
| * | K946281 | Eclipse 4 ElectrocardiographSummary page 1…ments (Rest ECG) K992637 Muse Cardiovascular Information System K974420 TraceMaster ECG Management System K946281 Burdick Eclipse 4 Electrocardiograph Device Description: INFINITY MegaCare is a computer software program tha… | 1996 |
What descends from it? (14)
See all 142 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 19 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K050858 (Heartlab, Inc., 2005) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K980625.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
INmm MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System. INmm MegaCare is intended to provide analysis or reanalysis of Rest ECG’s and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison…
Read the full statement (162 words)
INmm MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System.
INmm MegaCare is intended to provide analysis or reanalysis of Rest ECG’s and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG’s.
INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.
The device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition.
The device is intended for use with all patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031970: Infinity Megacare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031970
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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