# K022596: Bio-Cybernetic Cardio-Diagnosis System (BKD)

- Pathway: 510(k) (Traditional)
- Applicant: Clover Hi-Tech, Inc.
- Decided: Jan 31, 2003 after 179 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bio-Cybernetic Cardio Diagnostic System is intended to be used as an aid to diagnosis by means of analysis of the EKG waveform in the frequency domain (power spectral estimate).

Source page: https://510kreport.com/device/K022596
Methodology: https://510kreport.com/methodology