510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894492Substantially Equivalent

Nka Model Sec-3102 Cardiac Stimulator

Nihon Kohden America Inc, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894492 is the FDA 510(k) clearance record for NKA MODEL SEC-3102 CARDIAC STIMULATOR, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K894492.

Clearance record

Decision date
Received
(155 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
Nihon Kohden America, Inc. 17112 Armstrong Ave., Irvine 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260