510(k) · Cleared
ClearedEclipse 4 Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burdick, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Apr 23, 1996 after a 483-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Apr 23, 1996
- Review
- 483 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 5 citing it directly.
- This deviceK946281 Eclipse 4 ElectrocardiographBurdick, Inc. · 1996
- Descendant · cites it directly · 14 of its ownK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- Descendant · 3 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
- Descendant · 4 generations on · 6 of its ownK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K031970Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003 · cites it directly14descendants
- K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · cites it directly13descendants
- K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · 2 generations on8descendants
- K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 3 generations on7descendants
- K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946281 | Eclipse 4 Electrocardiograph | Burdick, Inc. | 1996 | — |
| +1 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| +2 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| +3 | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | 2 |
| +4 | K133534 | Mckesson Cardiology Ecg Mobile | Mckesson Israel, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 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 LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Marquette MAC PC Named without a submission number | |
| † | K943959 | Eclipse 4 Electrocardiograph | 1995 |
What descends from it? (19)
See all 195 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?
- Of its descendants, K031970 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 14 descendants of its own.
https://510kreport.com/device/K946281 · printed Nov 5, 2026
Cite this page
510(k) Report. “K946281: Eclipse 4 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946281
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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