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 May 17, 1995 after a 275-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 17, 1995
- Review
- 275 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK943959 Eclipse 4 ElectrocardiographBurdick, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK032051 Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P…Access Battery, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK160667 Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK071164 Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc. · 2004 · cites it directly1descendant
- K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017 · cites it directly0descendants
- K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943959 | Eclipse 4 Electrocardiograph | Burdick, Inc. | 1995 | — |
| +1 | K032051 | Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG… | Access Battery, Inc. | 2004 | — |
| +1 | K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | 2017 | — |
| +2 | K071164 | Life+Cel Battery | Amco International Manufacturing & Design, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 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? (3)
2 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, K032051 (Access Battery, Inc., 2004) has gone furthest, with 1 descendant of its own.
https://510kreport.com/device/K943959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943959: Eclipse 4 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943959
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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