Model Eli-100/ST Electrocardiograph

K895232510(k) TraditionalCleared Dec 13, 1989114-day review

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

Mortara Instrument, Inc. · LOS (no longer in FDA’s product-code list)

Cleared on Dec 13, 1989 after a 114-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: Dec 13, 1989
Review: 114 days
Product code: LOS
Recalls: None
Predicates: 0

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

This deviceK895232 Model Eli-100/ST ElectrocardiographMortara Instrument, Inc. · 1989
Descendant · cites it directly · 0 of its ownK942685 Ecg Review StationMortara Instrument, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K942685Ecg Review StationMortara Instrument, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K895232	Model Eli-100/ST Electrocardiograph	Mortara Instrument, Inc.	1989	—
+1	K942685	Ecg Review Station	Mortara Instrument, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K895232, 1989–1997Source: 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
K942685	Ecg Review Station	Mortara Instrument, Inc.	1997	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, K942685 (Mortara Instrument, Inc., 1997) has gone furthest, with 0 descendants of its own.

https://510kreport.com/device/K895232 · printed Nov 6, 2026

Cite this page

510(k) Report. “K895232: Model Eli-100/ST Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895232

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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