Archimed 4210 and 4220

K973922510(k) TraditionalCleared May 12, 1998209-day review

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

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

Cleared on May 12, 1998 as substantially equivalent to K902368 (Esaote Biomedica Spa, 1990) after a 209-day review. Its family tree reaches back 1 generation to 1990.

Decided: May 12, 1998
Review: 209 days
Product code: LOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K902368 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK902368 Personal 120/210 Basic ElectrocardiographEsaote Biomedica Spa · 1990
This deviceK973922 Archimed 4210 and 4220Biosound Esaote, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902368	Personal 120/210 Basic Electrocardiograph	Esaote Biomedica Spa	1990	—
0 (this device)	K973922	Archimed 4210 and 4220	Biosound Esaote, Inc.	1998	—

FIG. 1 — Lineage of K973922, 1990–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K902368	Personal 120/210 Basic Electrocardiograph Summary page 1 …ctrocardiograph data analysis firmware Classification Name(s): System, ECG Analysis 8§70.2340 Classification Number: 74L0S 807.92(a)(3) Predicate Device(s) Esaote P210 K902368 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. === Page…	Esaote Biomedica Spa	1990	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

What is it indicated for?

The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973922 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973922: Archimed 4210 and 4220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973922

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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