510(k) · Cleared
ClearedPatient Status Engine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isansys Lifecare, Ltd. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Apr 23, 2018 as substantially equivalent to K152139 (Vitalconnect, Inc., 2015) after a 264-day review. Its family tree reaches back 9 generations to 1997. 10 later devices descend from it.
- Decided
- Apr 23, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962603 (1997). 26 ancestors in all, the oldest K891104 (1989). 10 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK113054 EquivitalHidalgo Limited · 2012
- 2 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 1 generation backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- This deviceK172329 Patient Status EngineIsansys Lifecare, Ltd. · 2018
- Descendant · cites it directly · 6 of its ownK211305 ANNE OneSibel, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK223711 ANNE OneSibel Health, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK191620 Vitls PlatformVitls, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK213863 Everion+ SystemBiofourmis Singapore Pte., Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 3 generations backK113054 EquivitalHidalgo Limited · 2012
- 2 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 1 generation backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- This deviceK172329 Patient Status EngineIsansys Lifecare, Ltd. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K211305ANNE OneSibel, Inc. · 2021 · cites it directly6descendants
- K223711ANNE OneSibel Health, Inc. · 2023 · 2 generations on4descendants
- K191620Vitls PlatformVitls, Inc. · 2020 · cites it directly2descendants
- K242842ANNE View, Central HubSibel Health, Inc. · 2025 · 3 generations on1descendant
- K213863Everion+ SystemBiofourmis Singapore Pte., Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −3 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −1 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| 0 (this device) | K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | 2018 | — |
| +1 | K211305 | ANNE One | Sibel, Inc. | 2021 | — |
| +2 | K223711 | ANNE One | Sibel Health, Inc. | 2023 | — |
| +1 | K191620 | Vitls Platform | Vitls, Inc. | 2020 | — |
| +3 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
| +2 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatchSummary page 4…870.2910 Product Code: DRG Device Class: Class II Classification Panel: Cardiovascular 5. Legally Marketed Predicate Device K152139 - Vital Connect Platform/VitalPatch/HealthPatch MD by Vital Connect Inc. Sectio… | 2015 |
What descends from it? (10)
2 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 21 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K211305 (Sibel, Inc., 2021) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K152139.
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. 2018, 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?
The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient…
Read the full statement (164 words)
The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information.
The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172329: Patient Status Engine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172329
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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