Portable Instensive Care Unit

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

510(k) Number

K010207 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

ST

• 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

• Portable Intensive Care Unit Modification

  Class III

  FDA 510(k) K983307 Active Cleared 20 Nov 1998

• 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

See all devices from Medical Research Laboratories, Inc. →

• Is this device meant for use in ambulances or other pre-hospital settings, and if so, how does its portability factor into its design?

  Yes, the Portable Intensive Care Unit is explicitly designed for use in clinical environments requiring immediate cardiac intervention, including ambulances and pre-hospital emergency response. Its portability is a core feature, allowing it to be transported easily while providing advanced cardiac monitoring, defibrillation, and life-support functions in a compact format. This ensures critical care capabilities are available wherever they are needed.

• How is the Portable Intensive Care Unit supplied, and is it intended for single-use or reusable applications?

  The Portable Intensive Care Unit is supplied as a reusable medical device, meaning it is built for repeated use in clinical settings after proper cleaning, maintenance, and sterilization procedures. Unlike single-use devices, it is designed for long-term deployment in environments like hospitals, ambulances, and emergency response teams, where durability and reliability are essential.

• Does this device require any special handling or storage conditions, such as temperature or environmental protection?

  The provided data does not specify any special storage conditions like temperature ranges or environmental protections for the Portable Intensive Care Unit. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its functionality and longevity. Always follow the manufacturer’s guidelines for optimal care.

• What regulatory pathway was followed for FDA clearance, and how does this affect its classification and use?

  The Portable Intensive Care Unit was cleared through the FDA’s 510(k) pathway (K010207), classified under Class III (870.5310) as an Automated External Defibrillator (Non-Wearable). This classification indicates it is a high-risk device requiring stringent regulatory oversight. The clearance was granted under a Special 510(k) review, meaning it was evaluated for substantial equivalence to a predicate device while being subject to additional tracking requirements. This ensures compliance with rigorous safety and performance standards for critical cardiac care applications.