Heart and Respiration Rate Monitoring System Powered by EarlySense
by Baxter Healthcare Corproration
510(k) K223246
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223246 | Date18 Nov 2022 | 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- Withdrawn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
- Full name
- Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
- 510(k) Number
- FDA Product Code
- BZQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Breathing Frequency Monitor (OpenFDA classification) designed to continuously and non-invasively measure heart and respiration rates. It employs contact-free technology to provide real-time monitoring of vital signs, supporting clinical assessment in patient care settings.
The system is intended for use in hospital environments, particularly in perioperative and anesthesia care, as indicated by its advisory committee classification. It is supplied as a reusable device, with no explicit mention of sterility requirements in the provided data. The system operates within Class II regulatory classification (FDA 510(k) K223246) and is compatible with select bed models. No MRI safety or size-specific storage instructions are noted in the specifications.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is this device primarily designed for, and how does it support patient care in those areas?
The Hillrom Heart and Respiration Rate Monitoring System is specifically designed for use in hospital environments, particularly in perioperative and anesthesia care settings. It employs contact-free technology to continuously and non-invasively monitor heart and respiration rates in real-time, which helps clinicians assess patient stability during procedures and recovery. This is especially useful in anesthesia care, where precise monitoring of vital signs is critical for patient safety.
Is this device reusable, and if so, what considerations should be taken into account for its maintenance?
Yes, the Hillrom Heart and Respiration Rate Monitoring System is supplied as a reusable device. Since it is intended for use in clinical settings, proper cleaning, disinfection, and maintenance protocols must be followed to ensure hygiene and functionality. The manufacturer’s guidelines should be consulted for specific instructions on reprocessing, as no explicit sterility requirements are mentioned in the provided data.
What types of hospital beds is this device compatible with, and how does that affect its placement in a clinical setting?
The device is designed to be compatible with select bed models, though the exact specifications for compatibility are not detailed in the provided data. This compatibility ensures seamless integration into existing hospital infrastructure, allowing clinicians to monitor patients without the need for additional hardware. When selecting a bed, verify compatibility with the manufacturer’s recommendations to ensure proper functionality and placement.
How does the regulatory pathway for this device impact its use in clinical practice?
The device has undergone a 510(k) clearance process through the FDA, specifically classified as substantially equivalent under the regulatory pathway (K223246). This classification indicates that the device meets FDA standards for safety and effectiveness, allowing it to be used in clinical settings like perioperative and anesthesia care. The clearance also reflects that it falls under Class II regulatory classification, which typically requires additional controls to ensure its proper use and monitoring.
Are there any special storage instructions for this device, particularly regarding environmental conditions?
The provided data does not specify any special storage instructions, such as temperature or humidity requirements, or restrictions related to MRI safety. However, standard best practices for medical devices should be followed to maintain functionality, including protection from physical damage and contamination. Always refer to the manufacturer’s instructions for detailed storage guidelines.