510(k) · Cleared
ClearedANNE One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sibel Health, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Aug 10, 2023 as substantially equivalent to K211305 (Sibel, Inc., 2021) after a 241-day review. Its family tree reaches back 11 generations to 1997. 4 later devices descend from it.
- Decided
- Aug 10, 2023
- Review
- 241 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K962603 (1997). 28 ancestors in all, the oldest K891104 (1989). 4 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations between
- 3 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 2 generations backK172329 Patient Status EngineIsansys Lifecare, Ltd. · 2018
- 1 generation backK211305 ANNE OneSibel, Inc. · 2021
- This deviceK223711 ANNE OneSibel Health, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243837 iBSMIorbit Digital Technologies Private Limited · 2025
- Descendant · cites it directly · 0 of its ownK240251 ANNE ChestSibel Health, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK240305 ANNE LimbSibel Health, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 9 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 8 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 7 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 6 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 5 generations backK113054 EquivitalHidalgo Limited · 2012
- 4 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 3 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 2 generations backK172329 Patient Status EngineIsansys Lifecare, Ltd. · 2018
- 1 generation backK211305 ANNE OneSibel, Inc. · 2021
- This deviceK223711 ANNE OneSibel Health, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K242842ANNE View, Central HubSibel Health, Inc. · 2025 · cites it directly1descendant
- K243837iBSMIorbit Digital Technologies Private Limited · 2025 · cites it directly0descendants
- K240251ANNE ChestSibel Health, Inc. · 2024 · cites it directly0descendants
- K240305ANNE LimbSibel Health, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −10 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −9 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −8 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −7 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −6 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −5 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −4 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −3 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| −2 | K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | 2018 | — |
| −1 | K211305 | ANNE One | Sibel, Inc. | 2021 | — |
| 0 (this device) | K223711 | ANNE One | Sibel Health, Inc. | 2023 | — |
| +1 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
| +1 | K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025 | — |
| +1 | K240251 | ANNE Chest | Sibel Health, Inc. | 2024 | — |
| +1 | K240305 | ANNE Limb | Sibel Health, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 2 | 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 K242018 UbiqVue™ 2A Multi-parameter System (UX2550)score 20.3 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K211305 | ANNE OneSummary page 4…FR §870.2910 Regulatory Class: Class II Product Classification Code: DRG, MWI, FLL, DQA, MWJ, KMI III. Predicate Device Trade Name: ANNE One 510(k): K211305 Device Manufacturer: Sibel Health Inc. IV. Reference Devices Trade Name: ANNE Sleep 510(k): K220095… | 2021 |
| † | K220095 | ANNE Sleep | 2022 |
| † | K191614 | BioSticker System | 2019 |
| † | K141877 | Leaf Patient Monitoring System | 2014 |
| † | K212317 | Eclipse MINI Model 98900 | 2022 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K242842 (Sibel Health, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K211305.
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. 2023, 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?
ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature, and body temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure…
Read the full statement (203 words)
ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature, and body temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate, SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active.
ANNE One 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 threshold of time.
The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223711: ANNE One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223711
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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