510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872241Substantially Equivalent

Lifescope 12, Bsm 8500A Patient Monitor

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

K872241 is the FDA 510(k) clearance record for LIFESCOPE 12, BSM 8500A PATIENT MONITOR, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K872241.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Nihon Kohden America, Inc. 17112 Armstrong Ave., Irvine CA
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260