Portable Intensive Care Unit Modification

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Modification to Portable Intensive Care Unit

510(k) Number

K983307 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Porta Pak 90

  Class II

  FDA 510(k) K840900 Active Cleared 11 Jun 1984

• Dpd Defibrillator

  Class II

  FDA 510(k) K952085 Active Cleared 5 Jun 1995

• Porta Pulse III #D320

  Class II

  FDA 510(k) K833751 Active Cleared 11 Jan 1984

• Mrl Blood Pressure Monitor

  Class II

  FDA 510(k) K885191 Active Cleared 23 May 1989

• 450SLL Defibrillator

  Class II

  FDA 510(k) K874204 Active Cleared 28 Jan 1988

• Jump Start, Model 970300

  Class III

  FDA 510(k) K021168 Active Cleared 26 Jun 2002

See all devices from Medical Research Laboratories, Inc. →

• What types of cardiac emergencies is this modified portable intensive care unit designed to address specifically?

  This modification adds automated external defibrillation capabilities to a portable intensive care unit, targeting life-threatening cardiac arrhythmias like ventricular fibrillation or pulseless ventricular tachycardia. It is intended for use in out-of-hospital or pre-hospital settings where rapid intervention is critical.

• Is this device intended for single-use or reusable applications, and how does that affect its maintenance?

  The device can be configured for either single-use or reusable applications, depending on the specific components modified. Reusable components would require adherence to standard medical device reprocessing protocols to ensure safety and functionality, while single-use components would follow standard disposal guidelines.

• How does the size and transportability of this modified unit compare to standard defibrillators?

  The modification maintains the transportability typical of standard defibrillator units, ensuring it remains suitable for emergency response scenarios. Its design aligns with portable units, making it practical for out-of-hospital or pre-hospital use without compromising mobility.

• What regulatory pathway was used to authorize this modification, and what does that imply for its use?

  The modification was authorized through the FDA’s Special 510(k) pathway, demonstrating substantial equivalence to predicate devices. This pathway confirms compliance with FDA standards for Class III devices, ensuring the modification meets regulatory requirements for safety and effectiveness in defibrillation applications.