510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K884530Substantially Equivalent

Triad-Ep II, Plate Input

Cardiotronics, Inc., West Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884530 is the FDA 510(k) clearance record for TRIAD-EP II, PLATE INPUT, a class II device, cleared for Cardiotronics, Inc. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 27 510(k) clearances for Cardiotronics, Inc., from to . As of , FDA records show no recalls naming K884530.

Clearance record

Decision date
Received
(20 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
Cardiotronics, Inc. 2726 Loker Ave., West Carlsbad 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