510(k) · Cleared
ClearediBSM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iorbit Digital Technologies Private Limited · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 16, 2025 as substantially equivalent to K223711 (Sibel Health, Inc., 2023) and 1 other predicate after a 154-day review. Its family tree reaches back 13 generations to 1997.
- Decided
- May 16, 2025
- Review
- 154 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K962603 (1997). 46 ancestors in all, the oldest K891104 (1989). No later device cites it as a predicate yet.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK211305 ANNE OneSibel, Inc. · 2021
- 2 generations backK223711 ANNE OneSibel Health, Inc. · 2023
- 1 generation backK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- This deviceK243837 iBSMIorbit Digital Technologies Private Limited · 2025
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 8 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 7 generations backK113054 EquivitalHidalgo Limited · 2012
- 6 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 5 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 4 generations backK172329 Patient Status EngineIsansys Lifecare, Ltd. · 2018
- 3 generations backK211305 ANNE OneSibel, Inc. · 2021
- 2 generations backK223711 ANNE OneSibel Health, Inc. · 2023
- 1 generation backK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- This deviceK243837 iBSMIorbit Digital Technologies Private Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −8 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −7 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −6 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −5 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| −4 | K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | 2018 | — |
| −3 | K211305 | ANNE One | Sibel, Inc. | 2021 | — |
| −2 | K223711 | ANNE One | Sibel Health, Inc. | 2023 | — |
| −1 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
| 0 (this device) | K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K223711 | ANNE OneSummary page 7…70.2910 Regulatory Class: Class II Product Classification code: DRG, MWI,FLL,DQA,MWJ,KMI,DXN,BZQ Predicate Device: Primary Predicate Device Trade Name: ANNE One 510(k): K223711 Device Manufacturer: Sibel Health Inc. Secondary Predicate Device: Trade Name: ANNE View , Central Hub 510(k): K242842 Device Ma… | 2023 |
| * | K242842 | ANNE View, Central Hub Cleared while this submission was under review Summary page 7…ary Predicate Device Trade Name: ANNE One 510(k): K223711 Device Manufacturer: Sibel Health Inc. Secondary Predicate Device: Trade Name: ANNE View , Central Hub 510(k): K242842 Device Manufacturer: Sibel Health Inc. Reference Device: Trade Name: Blood Pressure Monitor 510(k): K193348 Device Manufacturer:… | 2025 |
| † | K193348 | Blood Pressure Monitor | 2020 |
| † | K240251 | ANNE Chest | 2024 |
| † | K240305 | ANNE Limb | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 10 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 46 ancestors have a recall of any class.
- 3 other devices also cite its predicate K223711.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (507 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243837: iBSM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243837
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026