510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011826Substantially Equivalent

Eps320 Cardiac Stimulator

Micropace Pty. Ltd., Campsie, N.S.W., AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011826 is the FDA 510(k) clearance record for EPS320 CARDIAC STIMULATOR, a class II device, cleared for Micropace Pty, Ltd. on under FDA product code JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)). FDA records list 3 510(k) clearances for Micropace Pty, Ltd., from to . As of , FDA records show no recalls naming K011826.

Clearance record

Decision date
Received
(227 days to decision)
Product code
JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Regulation
21 CFR 870.1750
Device class
Class II
Review panel
Cardiovascular
Applicant
Micropace Pty, Ltd. 571 Canterbury Rd., Campsie, N.S.W., AU
510(k) summary
Summary
Third party review
No

Clearances, product code JOQ

Trailing 12 months

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

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