Portable Intensive Care Unit

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

510(k) Number

K012766 ↗

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 the Portable Intensive Care Unit (PIC) designed for single-use or can it be reused after proper cleaning and maintenance?

  The Portable Intensive Care Unit is intended for reuse and must undergo proper cleaning, disinfection, and maintenance between uses to ensure safety and functionality. Since it is not sterile, adherence to manufacturer guidelines for reprocessing is critical to maintain performance and prevent contamination.

• What types of therapeutic interventions can the PIC deliver, and where is it primarily used?

  The PIC is designed to deliver defibrillation, pacing, and ventilation while providing real-time patient monitoring of vital signs. It is intended for use in hospital emergency departments, pre-hospital emergency care, and critical care transport, where traditional intensive care facilities are unavailable.

• How should the Portable Intensive Care Unit be stored, and what environmental considerations apply?

  The PIC must be stored in accordance with manufacturer guidelines to preserve its operational integrity. It is not MRI-safe, meaning it should be kept in environments where MRI procedures are not conducted, as exposure to MRI fields could compromise its function or safety.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The Portable Intensive Care Unit received FDA 510(k) clearance (K012766) under the Traditional pathway, classified as a Class III device under the Automated External Defibrillators (Non-Wearable) category (Product Code MKJ). It is regulated under FDA regulation number 870.5310 and was reviewed by the Cardiovascular (CV) Advisory Committee.

• Does the Portable Intensive Care Unit require any special handling or maintenance beyond routine cleaning?

  Beyond cleaning and disinfection, the PIC requires regular maintenance to ensure proper functionality. Since it is a reusable medical device, adherence to the manufacturer’s reprocessing protocols is essential to prevent malfunctions, ensure patient safety, and extend the device’s operational lifespan.