# K243837: iBSM

- Pathway: 510(k) (Traditional)
- Applicant: Iorbit Digital Technologies Private Limited
- Decided: May 16, 2025 after 154 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223711: ANNE One, Sibel Health, Inc. (2023) Summary page 7.
- K242842: ANNE View, Central Hub, Sibel Health, Inc. (2025). Cleared while this submission was under review Summary page 7.

## Indications for use
iBSM is a wireless monitoring system intended for the display of electrocardiography (ECG) waveform, heart rate measurements, respiratory rate measurement and waveform, functional oxygen saturation of arterial hemoglobin (SpO2), activity, body position, fall detection, skin temperature and Blood Pressure parameter measurements by qualified healthcare professionals in healthcare settings. iBSM continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient’s position has not changed from a preset time threshold. The iBSM device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The iBSM device is not intended for use on critical care patients. The iBSM BP cuff is not intended for subjects that are considered special populations. The iBSM device is indicated for monitoring ECG waveforms and heart rate on non-ambulatory patients. The iBSM device is intended to be used in wards and patient rooms in professional healthcare facility environment hospital settings. The iBSM device is not intended to be used in Home environment or special environment. The iBSM device is not intended to be used in an ambulatory environment for noninvasive blood pressure, respiratory rate and SpO2 measurement parameters. The iBSM device is not intended to monitor or measure respiratory rate, SpO2, or noninvasive blood pressure while the patient undergoes significant motion or is active. The iBSM device is not intended to be used in the ICU/CCU or Surgery/OT rooms iBSM is compatible with third-party, FDA cleared devices such as ANNE Chest from Sibel Health Inc, for ECG, HR, RR, body position and skin temperature measurements; and ANNE Limb from Sibel Health Inc. for SpO2 and skin temperature measurements. iBSM is compatible with third-party, FDA-cleared BP devices such as BP2A from Shenzhen Viatom, for non-invasive blood pressure measurements. The iBSM device communicates with an external server for patient data communication and storage. The iBSM device includes the ability to notify healthcare professionals when physiological data fall outside selected parameters with the use of audio and visual alarms. The iBSM chest sensor is not intended to be used to provide diagnostic or or interpretive statements to either the patient or the clinician. The iBSM chest sensor is NOT intended to be used on critical care patients and is not a remote diagnostic device. The iBSM chest sensor is NOT intended for use on patients with implanted pacemakers. The iBSM Chest sensor is NOT intended for use on patients with known allergies, or hypersensitivities to, adhesives or nickel. The iBSM Chest Sensor is NOT intended for patients with significant cardiorespiratory disease including patients that are oxygen dependent. The iBSM Chest Sensor is NOT intended for patients with significant respiratory muscle weakness due to an underlying neuromuscular condition (e.g.,myasthenia gravis, amyotrophic lateral sclerosis, or muscular dystrophies) The data and results provided by the BP cuff device are for precheck screening purposes only and cannot be directly used for diagnosis or treatments.

Source page: https://510kreport.com/device/K243837
Methodology: https://510kreport.com/methodology