OneStep Adult Multi-Function Electrode
510(k) K110742
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110742 | Date13 Apr 2011 | StatusActive |
Recalls
-
- Terminated Z-0977-2018
A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk.
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- Withdrawn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 OneStep Adult Multi-Function Electrode is a reusable adhesive electrode designed for use with automated external defibrillators (non-wearable). It is intended for delivering defibrillation shocks and monitoring cardiac activity in adult patients during resuscitation efforts. This electrode combines multiple functions, including defibrillation and electrocardiogram (ECG) monitoring, into a single device.
Supplied as a reusable component, the electrode is intended for use in emergency and clinical settings where defibrillation and ECG monitoring are required. It is not classified as single-use and must be cleaned and maintained according to manufacturer guidelines. The device is classified under FDA regulation number 870.5310 and is authorized via FDA 510K clearance (K110742). No specific MRI safety information is provided, and proper storage conditions should be followed to ensure functionality and sterility.
Other devices from Zoll Medical Corporation
Questions
AI-generated answers, 18 Sep 2026
Is the OneStep Adult Multi-Function Electrode designed for single-use or can it be reused?
The OneStep Adult Multi-Function Electrode is explicitly designed for reuse, not single-use. Since it is classified as a reusable adhesive electrode, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and safety during repeated use with automated external defibrillators (non-wearable).
What types of settings is this electrode intended for, and how is it supplied?
This electrode is intended for emergency and clinical settings where defibrillation and ECG monitoring are required, such as hospitals, ambulances, or public access defibrillation programs. It is supplied as a reusable component and must be cleaned and maintained per manufacturer instructions to ensure reliability.
Does the OneStep Adult Multi-Function Electrode require any special storage conditions to maintain sterility or functionality?
While the device is reusable and not single-use, proper storage conditions are still critical to preserve its functionality and hygiene. The manufacturer recommends following specific storage guidelines to ensure the electrode remains effective for repeated use, though no explicit sterility claims are made for reuse. Always refer to the manufacturer’s instructions for detailed storage protocols.
What regulatory pathway was followed for FDA clearance of this electrode, and what classification does it fall under?
The OneStep Adult Multi-Function Electrode received FDA 510(k) clearance (K110742) under the classification of Class III (as indicated by the openFDA device class) and falls under FDA regulation number 870.5310. The clearance was granted through a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee, with a special clearance type.