Elite II Electrocardiograph

K904032510(k) TraditionalCleared Jul 24, 1991327-day review

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Burdick Corp. · LOS (no longer in FDA’s product-code list)

Cleared on Jul 24, 1991 after a 327-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Jul 24, 1991
Review: 327 days
Product code: LOS
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK904032 Elite II ElectrocardiographBurdick Corp. · 1991
Descendant · cites it directly · 0 of its ownK981951 CT 100 ElectrocardiographMacquarie Medical Systems · 1998

Most influential descendants

Showing 1 of 1 · See all

K981951CT 100 ElectrocardiographMacquarie Medical Systems · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K904032	Elite II Electrocardiograph	Burdick Corp.	1991	—
+1	K981951	CT 100 Electrocardiograph	Macquarie Medical Systems	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K904032, 1991–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K981951	CT 100 Electrocardiograph	Macquarie Medical Systems	1998	0

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, K981951 (Macquarie Medical Systems, 1998) has gone furthest, with 0 descendants of its own.

https://510kreport.com/device/K904032 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904032: Elite II Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904032

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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