510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K022596Substantially Equivalent

Bio-Cybernetic Cardio-Diagnosis System (Bkd)

Clover Hi-Tech, Inc., City Of Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022596 is the FDA 510(k) clearance record for BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD), a class II device, cleared for Clover Hi-Tech, Inc. on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list one 510(k) clearance for Clover Hi-Tech, Inc. As of , FDA records show no recalls naming K022596.

Clearance record

Decision date
Received
(179 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Clover Hi-Tech, Inc. 17800 Castleton St., City Of Industry CA
510(k) summary
Statement
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261