510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882168Substantially Equivalent

External Pacemaker 2000 (Ep2000)

Unomed, Inc., Ft. Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882168 is the FDA 510(k) clearance record for EXTERNAL PACEMAKER 2000 (EP2000), a class II device, cleared for Unomed, Inc. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list one 510(k) clearance for Unomed, Inc. As of , FDA records show no recalls naming K882168.

Clearance record

Decision date
Received
(87 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
Unomed, Inc. 13180 N. Cleveland Ave., Ft. Myers FL
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