Ekg-Plus II Software

K090895510(k) TraditionalCleared Aug 26, 2009149-day review

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

Bionet Co., Ltd. · LOS (no longer in FDA’s product-code list)

Cleared on Aug 26, 2009 as substantially equivalent to K974352 (Micromedical, Inc., 1998) after a 149-day review. Its family tree reaches back 1 generation to 1998.

Decided: Aug 26, 2009
Review: 149 days
Product code: LOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K974352 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK974352 Cardioview 3000 SoftwareMicromedical, Inc. · 1998
This deviceK090895 Ekg-Plus II SoftwareBionet Co., Ltd. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974352	Cardioview 3000 Software	Micromedical, Inc.	1998	—
0 (this device)	K090895	Ekg-Plus II Software	Bionet Co., Ltd.	2009	—

FIG. 1 — Lineage of K090895, 1998–2009Source: 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

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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
*	K974352	Cardioview 3000 Software Summary page 1 …ECG Analysis System Classification Name: ECG Analysis System, product code LOS Predicate Device: CARDIOVIEW ECG Interpretive Software (K974352) Device Description: The EKG-PLUS 11Software is a program which receives, displays, stores and prints out in network environment…	Micromedical, Inc.	1998	—

Also cleared against K974352: 1 other device →

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.
1 other device also cites its predicate K974352.

What is it indicated for?

EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device- CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090895 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090895: Ekg-Plus II Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090895

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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