510(k) · Cleared
ClearedVitls Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitls, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 1, 2020 as substantially equivalent to K172329 (Isansys Lifecare, Ltd., 2018) and 1 other predicate after a 349-day review. Its family tree reaches back 10 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 1, 2020
- Review
- 349 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K962603 (1997). 32 ancestors in all, the oldest K891104 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 2 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 1 generation backK172329 Patient Status EngineIsansys Lifecare, Ltd. · 2018
- This deviceK191620 Vitls PlatformVitls, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK213863 Everion+ SystemBiofourmis Singapore Pte., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK233418 Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 7 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 6 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 5 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 4 generations backK113054 EquivitalHidalgo Limited · 2012
- 3 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 2 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 1 generation backK172329 Patient Status EngineIsansys Lifecare, Ltd. · 2018
- This deviceK191620 Vitls PlatformVitls, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −7 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −6 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −5 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −4 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −3 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −2 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| −1 | K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | 2018 | — |
| 0 (this device) | K191620 | Vitls Platform | Vitls, Inc. | 2020 | — |
| +1 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | — |
| +2 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 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 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K172329 | Patient Status EngineSummary page 4…gnal transmitter Regulation Numbers: 21 CFR 870.2910 Product Codes: DRG Predicate Devices: Isansys Lifecare Ltd. Patient Status Engine cleared in K172329 Vivalnk FeverScout cleared in K162137 Device Description and Technological Characteristics: The… | 2018 |
| * | K162137 | Fever Scout™ Continuous Monitoring thermometerSummary page 4…duct Codes: DRG Predicate Devices: Isansys Lifecare Ltd. Patient Status Engine cleared in K172329 Vivalnk FeverScout cleared in K162137 Device Description and Technological Characteristics: The Vitls Platform is a wireless multi-parameter vital signs… | 2017 |
| † | K073462 | Modification to Dash 3000, 4000, 5000 Monitor and Accessories | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213863 | Everion+ System | 2023 | 1 |
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 23 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 32 ancestors have a recall of any class.
- Of its descendants, K213863 (Biofourmis Singapore Pte., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K172329.
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. 2020, 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 Vitls Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in healthcare and home settings. This includes heart rate (HR) and body temperature. The data from the Tego VSS Sensor 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.
The device is intended for use as a general patient monitor, to provide physiological information, on patients who are 2 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191620: Vitls Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191620
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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