510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883334Substantially Equivalent

Biodop(tm)

Diagnosis Related Systems, Inc., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883334 is the FDA 510(k) clearance record for BIODOP(TM), a class II device, cleared for Diagnosis Related Systems, Inc. on under FDA product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic). FDA records list one 510(k) clearance for Diagnosis Related Systems, Inc. As of , FDA records show no recalls naming K883334.

Clearance record

Decision date
Received
(128 days to decision)
Product code
HEK Monitor, Heart Sound, Fetal, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Diagnosis Related Systems, Inc. 7760 W. 20th Ave., Unit 11, Hialeah FL
Third party review
No

Clearances, product code HEK

Trailing 12 months

FDA records hold no clearances under product code HEK in the trailing twelve months.

FDA records show no clearances under product code HEK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260