Cardiotouch-3000

K023034510(k) SpecialCleared Nov 14, 200263-day review

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

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

Cleared on Nov 14, 2002 as substantially equivalent to K011328 (Bionet Company, Ltd., 2001) after a 63-day review. Its family tree reaches back 1 generation to 2001.

Decided: Nov 14, 2002
Review: 63 days
Product code: LOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011328 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK011328 Cardio Care Ekg-2000 12-Channel ElectrocardiographBionet Company, Ltd. · 2001
This deviceK023034 Cardiotouch-3000Bionet Company, Ltd. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011328	Cardio Care Ekg-2000 12-Channel Electrocardiograph	Bionet Company, Ltd.	2001	—
0 (this device)	K023034	Cardiotouch-3000	Bionet Company, Ltd.	2002	—

FIG. 1 — Lineage of K023034, 2001–2002Source: 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
*	K011328	Cardio Care Ekg-2000 12-Channel Electrocardiograph Summary page 2 …ially equivalent to other medical devices in commercial distribution. Also. Equivalency detailed chart path is attached. FDA f& rserence number 510kffk011328 Attaclunents inside 510k summaiy print out notification submission file TECHNOLOGICAL CHARACTERISTIC…	Bionet Company, Ltd.	2001	—

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 CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023034: Cardiotouch-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023034

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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