Connexall Suite of Software Products
510(k) K112650
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112650 | Date1 Feb 2012 | 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- Withdrawn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
- MSX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Connexall Suite of Software Products is a System, Network and Communication Device designed for physiological monitoring. It integrates with patient monitoring systems to transmit real-time status and alarm data to authorized users via third-party mobile or display devices, facilitating remote clinical oversight and workflow coordination in healthcare settings.
This software solution is intended for on-site use within clinical environments, requiring integration with existing monitor networks. It is classified as a Class II device under FDA regulations (21 CFR 870.2300) and has received FDA 510(k) clearance (K112650) as substantially equivalent to predicate devices. The system is not single-use or reusable but operates as a standalone software platform, with no specified sterility or MRI safety considerations. Distribution and use are governed by the manufacturer’s software licensing terms and FDA-compliant deployment guidelines.
Questions
AI-generated answers, 20 Sep 2026
What clinical environments is the Connexall Suite of Software Products designed to support, and how does it integrate with existing systems?
The Connexall Suite is designed for on-site use within clinical environments like hospitals, intensive care units, or cardiac care settings where real-time patient monitoring is critical. It integrates with existing patient monitoring systems to transmit physiological data, alarms, and status updates to authorized users via third-party mobile devices or displays. This enables remote clinical oversight and improves workflow coordination without requiring standalone hardware.
Is the Connexall Suite a single-use or reusable product, and does it require sterilization?
The Connexall Suite is a standalone software platform and is neither single-use nor reusable. Since it operates digitally and does not involve physical contact with patients or sterile environments, sterilization is not applicable. Its functionality relies entirely on software deployment and integration with existing networks.
How is the Connexall Suite regulated, and what does its FDA clearance status mean for healthcare providers?
The Connexall Suite is classified as a Class II medical device under FDA regulations (21 CFR 870.2300) and holds a 510(k) clearance (K112650), meaning it has been deemed substantially equivalent to predicate devices. This clearance confirms the product meets FDA safety and effectiveness standards for use in clinical settings, though providers must follow the manufacturer’s licensing terms and FDA-compliant deployment guidelines for proper implementation.
Does the Connexall Suite have any compatibility or safety considerations for use with MRI equipment?
The Connexall Suite is a software-based solution and does not involve physical hardware that would interact with MRI environments. Therefore, there are no specified MRI safety considerations or compatibility requirements for this product. Its use remains confined to on-site clinical monitoring systems and does not involve exposure to MRI fields.
What types of physiological monitoring systems can the Connexall Suite integrate with, and are there limitations to its compatibility?
The Connexall Suite integrates with a broad range of patient monitoring systems, as evidenced by its FDA registration under multiple product codes (e.g., MSX) for physiological monitors. While it supports integration with existing networks, compatibility depends on the manufacturer’s specifications for the specific monitoring systems in use. Healthcare providers should verify compatibility with their current infrastructure before deployment.