ResQCPR System

No FDA recalls found in the data synced 6 Oct 2026.

Generic name

Combination compression/decompression manual chest pump with impedance respiratory valve

PMA number

P110024 ↗

FDA product code

PIZ

Device class

Class III

Advisory committee

Cardiovascular

FDA decision

APPR Approved

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See all devices from Zoll Medical Corporation →

• What is the primary purpose of the ResQCPR System in a cardiac arrest scenario, and how does it differ from traditional manual CPR?

  The ResQCPR System is designed as a **manual chest pump** that provides **both compressions and decompressions** during CPR for adult patients in non-traumatic cardiac arrest. Unlike traditional manual CPR, which relies solely on chest compressions, this device actively assists by decompressing the chest between compressions. This mechanical decompression improves blood flow and oxygenation, potentially increasing the likelihood of survival for patients in cardiac arrest. It is intended as an adjunct to manual CPR, not a replacement.

• Is the ResQCPR System single-use or reusable, and what maintenance or training is required for its use?

  The ResQCPR System is **reusable** and requires **proper training** for operation and maintenance. Since it is not a sterile device (as indicated by its reusable classification), it must be cleaned, inspected, and maintained according to the manufacturer’s guidelines to ensure reliable performance. Hospitals and pre-hospital settings must train personnel on its use to ensure correct application during emergencies.

• What types of environments is the ResQCPR System intended for, and are there any restrictions on its use?

  The ResQCPR System is **intended for emergency medical settings**, including both **pre-hospital (e.g., ambulances, EMS) and in-hospital environments** where manual CPR is being performed. It is **not approved for MRI use**, meaning it should not be placed in or near an MRI scanner. Additionally, its use is limited to **adult patients with non-traumatic cardiac arrest**—it is not indicated for pediatric or traumatic cases.

• How is the ResQCPR System regulated, and what does the PMA approval signify?

  The ResQCPR System holds a **PMA (Premarket Approval) approval (P110024)** from the FDA, classifying it as a **Class III medical device**. This means it underwent rigorous review by the FDA’s **Cardiovascular (CV) advisory committee** to demonstrate safety and effectiveness as a **CPR adjunct** for improving survival in adult non-traumatic cardiac arrest. The approval signifies that the device meets stringent regulatory standards for life-saving applications.

• What storage requirements should be followed to maintain the ResQCPR System’s functionality and readiness for use?

  The ResQCPR System must be stored **according to the manufacturer’s guidelines** to ensure proper functionality and longevity. While not explicitly stated as sterile, it should be kept in a **clean, dry environment** protected from physical damage or contamination. Regular inspections and maintenance (as outlined in the manufacturer’s instructions) are critical to ensure reliability during emergency deployments.