ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
510(k) K162768
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162768 | Date16 Aug 2017 | 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- Withdrawn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
- DSA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2900
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Cable, Transducer and Electrode, Patient (Including Connector) designed to interface physiological sensors with monitoring equipment. It facilitates the transmission of electrical signals from patient-applied electrodes (ECG leads), SpO₂ sensors, and invasive blood pressure (IBP) transducers to diagnostic devices. The cables include multi-lead configurations, trunk cables, and specialized leadwires for ECG monitoring, ensuring reliable signal conduction for cardiovascular assessment.
The device is supplied as reusable electrical cables and leadwires, intended for use in hospital, clinic, emergency, and home settings by healthcare professionals. It is classified under FDA regulation 870.2900 and holds an FDA 510(k) clearance (K162768) under an abbreviated submission, deemed substantially equivalent to predicate devices. No specific sterility or single-use designation is stated; compatibility with MRI environments is not addressed in the data. Multiple FEI numbers reference various cable configurations, indicating modular adaptability for different monitoring systems.
Other devices from Integral Process Sas
Questions
AI-generated answers, 1 Oct 2026
What is the Integral Process ECG multi-lead cable used for?
The Integral Process ECG multi-lead cable is designed to interface physiological sensors—including ECG leads, SpO₂ sensors, and invasive blood pressure (IBP) transducers—with monitoring equipment. It ensures clear transmission of electrical signals for accurate cardiovascular assessment in settings like hospitals, clinics, emergency rooms, and patient homes. The modular design supports various monitoring systems, making it adaptable for different clinical needs.
Are these cables reusable or single-use?
The Integral Process ECG multi-lead cables are explicitly described as reusable electrical cables and leadwires. Unlike single-use devices, these are intended for repeated use in clinical environments, provided they are properly cleaned and maintained between applications. No sterility designation is specified, so adherence to manufacturer cleaning protocols is critical for safe reuse.
What types of configurations or models are available?
This device includes multiple configurations, such as ECG multi-lead cables, Monobloc ECG cables, SpO₂ sensor interface cables, and IBP transducer interface cables. It also features specialized leadwires for both Integral Process trunk cables and original trunk cables. The extensive list of FEI numbers (e.g., 3001236763, 1018233) reflects modular adaptability, allowing compatibility with various monitoring systems and setups.
How should these cables be stored?
While specific storage instructions aren’t detailed in the provided data, reusable medical cables like these typically require protection from physical damage, moisture, and contamination. Storage in a clean, dry environment—preferably in a designated medical equipment cabinet or pouch—is recommended. Avoid bending or kinking the cables excessively, as this can compromise signal integrity. Always follow the manufacturer’s guidelines for optimal longevity.
What regulatory pathway does this device follow?
The Integral Process ECG multi-lead cables are classified under FDA regulation 870.2900 and hold an FDA 510(k) clearance (K162768). The clearance was granted through an abbreviated submission, deemed substantially equivalent to predicate devices. This classification falls under the Cardiovascular advisory committee, ensuring compliance with U.S. medical device regulations for cardiovascular monitoring equipment.