Lumineb I

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K884722 ↗

FDA Product Code

BTI

Device Class

Class II

Regulation

21 CFR Part 868.6250

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Lumiscope Model 1000/APCC Model 1000

  Class II

  FDA 510(k) K894127 Active Cleared 6 Sep 1989

• Lumisonic

  Class II

  FDA 510(k) K924081 Active Cleared 9 Nov 1992

• Infrared Lamp

  Class II

  FDA 510(k) K925054 Active Cleared 29 Jun 1993

• Cardicare Model Mt-301F & Mt-301C

  Class II

  FDA 510(k) K032714 Active Cleared 22 Oct 2003

• Lumiscope Electrodes Models El-08, 11, 15, 06, 21, 25

  Class II

  FDA 510(k) K901809 Active Cleared 18 Jun 1990

• Lumiscope Ems 8000

  Class II

  FDA 510(k) K901849 Active Cleared 24 Aug 1990

See all devices from Lumiscope Co., Inc. →