510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854196Substantially Equivalent

Dci Model Ep-2 Clinical Stimulator

Digital Cardiovascular Instruments, Inc., Emeryville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854196 is the FDA 510(k) clearance record for DCI MODEL EP-2 CLINICAL STIMULATOR, a class II device, cleared for Digital Cardiovascular Instruments, Inc. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list one 510(k) clearance for Digital Cardiovascular Instruments, Inc. As of , FDA records show no recalls naming K854196.

Clearance record

Decision date
Received
(198 days to decision)
Product code
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Applicant
Digital Cardiovascular Instruments, Inc. 1715 64th. St., Emeryville CA
Third party review
No

Clearances, product code DRO

Trailing 12 months

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

FDA records show no clearances under product code DRO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRO, 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