Instacine

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K942558 ↗

FDA Product Code

LMB

Device Class

Class I

Regulation

21 CFR Part 892.2010

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Fluoroplua Cardiac and/or Instaview

  Class II

  FDA 510(k) K941917 Active Cleared 24 Feb 1995

• LP-Plus

  Class II

  FDA 510(k) K903774 Active Cleared 29 Aug 1991

• Instacine D-2000

  Class II

  FDA 510(k) K983088 Active Cleared 22 Sep 1998

• Clinical Electronic Thermometer

  Class II

  FDA 510(k) K841780 Active Cleared 6 Jul 1984

• LP-3 Electrocardiograph

  Class II

  FDA 510(k) K864614 Active Cleared 16 Jun 1987

• Instaspot

  Class II

  FDA 510(k) K942504 Active Cleared 5 May 1995

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