Zoll PD 1600 Semi-Automatic External Defibrillator
510(k) K942344
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942344 | Date13 Mar 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Zoll PD 1600 Semi-Automatic External Defibrillator is a Class III medical device designed for the delivery of electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It operates in both semi-automatic and manual modes, providing automated shock advisory or manual override capabilities to healthcare providers.
This device is intended for use in clinical settings such as hospitals and emergency response environments. Supplied as a reusable medical instrument, it requires proper maintenance and calibration per manufacturer guidelines. Authorized for use in the United States under an FDA 510(k) clearance (K942344), it adheres to regulatory standards for cardiovascular devices and is classified under the product code MKJ.
Other devices from Zoll Medical Corporation
Questions
AI-generated answers, 18 Sep 2026
Is the Zoll PD 1600 Semi-Automatic External Defibrillator designed for single-use or reusable in clinical settings, and what maintenance is required?
The Zoll PD 1600 is a reusable medical device intended for use in clinical settings like hospitals and emergency response environments. Since it is reusable, it requires regular maintenance and calibration as specified by the manufacturer to ensure proper functionality and safety. The device’s design supports repeated use under proper care and servicing protocols.
What modes of operation does the Zoll PD 1600 Semi-Automatic External Defibrillator support, and how does that affect its use by healthcare providers?
The Zoll PD 1600 operates in both semi-automatic and manual modes. In semi-automatic mode, it provides automated shock advisory—meaning it analyzes the patient’s heart rhythm and suggests when a shock may be needed. However, healthcare providers can also override this recommendation and manually deliver a shock if clinically indicated. This dual-mode capability ensures flexibility for providers based on patient needs and clinical judgment.
What regulatory pathway was followed for FDA clearance of the Zoll PD 1600, and what does that mean for its classification and intended use?
The Zoll PD 1600 received FDA 510(k) clearance (K942344) under a Traditional 510(k) pathway, determined to be substantially equivalent to a legally marketed predicate device. This classification places it as a Class III device (as noted in OpenFDA) and confirms its intended use for delivering electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee, aligning with regulatory standards for cardiovascular defibrillators.
How is the Zoll PD 1600 Semi-Automatic External Defibrillator categorized in terms of medical specialty and regulatory compliance?
The device is categorized under the medical specialty of Cardiovascular and adheres to FDA regulation 870.5310, which governs automated external defibrillators. Its product code (MKJ) further confirms its classification as a cardiovascular device intended for emergency cardiac resuscitation. These categorizations ensure it meets strict safety and performance standards for use in clinical and pre-hospital settings.