Portable Intensive Care Unit

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

510(k) Number

K012030 ↗

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

• 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. →

• Can this device be used in both pre-hospital and hospital settings, and how is it supplied for these environments?

  Yes, the Portable Intensive Care Unit is explicitly designed for use in both pre-hospital and out-of-hospital emergency settings, including cardiac care units. It is supplied as a portable unit, making it suitable for transport and immediate deployment in critical situations where defibrillation is required. The portability ensures it can be easily moved to where patients need it most, whether in an ambulance, emergency room, or other clinical environments requiring rapid response.

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

  The Portable Intensive Care Unit can be used for either single-use or reusable applications, depending on the specific model and configuration. For reusable models, proper maintenance and sterilization procedures must be followed to ensure safety and functionality. Since it is classified as a Class III device, adherence to manufacturer guidelines for cleaning, disinfection, and inspection is critical to prevent contamination and ensure reliable performance over repeated uses.

• What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed the submission?

  The Portable Intensive Care Unit received FDA 510(k) clearance through the Traditional pathway, which involves a detailed review by the FDA to determine substantial equivalence to a legally marketed predicate device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, ensuring expert input from specialists in cardiovascular devices before clearance was granted.

• How does the device’s classification as Class III impact its use in clinical settings?

  As a Class III medical device, the Portable Intensive Care Unit is subject to stringent regulatory controls due to its high-risk nature, particularly in life-supporting applications like defibrillation. This classification ensures rigorous manufacturing, testing, and quality assurance processes to guarantee safety and effectiveness. Clinicians must follow manufacturer instructions precisely, including proper training, to operate the device correctly and maintain compliance with regulatory standards.