510(k) · Cleared
ClearedMegacart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Burdick, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Jul 1, 1992 after a 224-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Jul 1, 1992
- Review
- 224 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 2 citing it directly.
- This deviceK915225 MegacartSiemens Burdick, Inc. · 1992
- Descendant · cites it directly · 23 of its ownK980625 Siemens Multiview Workstation Enhanced with Diagnostic Statements…Siemens Medical Solutions USA, Inc. · 1998
- Descendant · 2 generations on · 14 of its ownK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 3 generations on · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- Descendant · cites it directly · 8 of its ownK974698 Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment AnalysisSiemens Medical Solutions USA, Inc. · 1998
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K980625Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg)Siemens Medical Solutions USA, Inc. · 1998 · cites it directly23descendants
- K031970Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on14descendants
- K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · 3 generations on13descendants
- K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · 3 generations on8descendants
- K974698Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment AnalysisSiemens Medical Solutions USA, Inc. · 1998 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915225 | Megacart | Siemens Burdick, Inc. | 1992 | — |
| +1 | K980625 | Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg) | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +2 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +3 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| +3 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| +1 | K974698 | Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis | Siemens Medical Solutions USA, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 252 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, K980625 (Siemens Medical Solutions USA, Inc., 1998) has gone furthest, with 23 descendants of its own.
https://510kreport.com/device/K915225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915225: Megacart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915225
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026