510(k) · Cleared
ClearedBettercare Platform - Advanced Web Client
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Care S.L. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 5, 2018 as substantially equivalent to K122133 (Airstrip Technologies, LP, 2012) after a 272-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Feb 5, 2018
- Review
- 272 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122133 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backK122133 Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 2012
- This deviceK171361 Bettercare Platform - Advanced Web ClientBetter Care S.L. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing | Airstrip Technologies, LP | 2012 | — |
| 0 (this device) | K171361 | Bettercare Platform - Advanced Web Client | Better Care S.L. | 2018 | — |
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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingSummary page 5…OF COMPARISON WITH PREDICATE DEVICE: BetterCare Platform - Advanced Web Client is compared with the following previously cleared devices: Airstrip RPM (K122133) - Primary Predicate Web Viewer, Pocket Viewer and Cellular Viewer (K061994) - Reference Predicate Comparison o… | 2012 |
| † | K061994 | Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 Software | 2006 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K122133.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured from patient monitors by the Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wired or wireless devices running the Advanced Web Client application. The information…
Read the full statement (443 words)
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured from patient monitors by the Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wired or wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only. The BetterCare Platform is not indicated for use as a real-time monitor.
The BetterCare Platform - Advanced Web Client is intended to display data and waveforms from attached medical devices in a pass-though fashion, the BetterCare Platform - Advanced Web Client is agnostic to the age or condition of patients attached to the medical devices from which data is received. For example, the special requirements for neonatal, pediatric or adult patients are all provided by the medical devices directly attached to the patient. The BetterCare Platform - Advanced Web Client simply reproduces that numeric, waveform and other clinical data provided to it for communications and display.
The BetterCare Platform - Advanced Web Client is installed on compatible desktop and mobile devices, including cellular telephones, and is intended to be used by clinicians to:
- remotely view patient physiological information as captured by Draeger Infinity Gateway
- remotely view waveforms as captured by Draeger Infinity Gateway
- remotely view other patient data as captured by Draeger Infinity Gateway
The BetterCare Platform - Advanced Web Client is not patient connected and is not a primary alarm source. It can display the following physiological data captured by Draeger Infinity Gateway:
- ECG Waveform
- Arterial Pressure Waveform
- SpO2 Waveform
- CO2 Waveform
- Central Venous Pressure Waveform
- Pulmonary Arterial Pressure Waveform
- Right Auricular Pressure Waveform
- Left Auricualar Pressure Waveform
- Resp Waveform
- Heart Rate
- Respiratory Rate
- Oxygen Saturation
- Central Venous Pressure
- Systolic Arterial Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Arterial Pressure Invasive
- Systolic Blood Pressure Non invasive
- Mean Bloood Pressure Non invasive
- Diastolic Blood Pressure Non invasive
- Systolic Pulmonary Arterial Pressure
- Mean Pulmonary Arterial Pressure
- Diastolic Pulmonary Arterial Pressure
- Right Auricular Pressure
- Left Auricular Pressure
BetterCare Platform Advanced Web Client is intended to be installed on wired and wireless devices, including cellular telephones, and is not intended to be used where such devices are prohibited.
BetterCare Platform Advanced Web Client is intended for use by trained clinicians in hospital environments as a diagnostic aid and not as a replacement for direct viewing of any of the monitoring devices interfaced.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171361: Bettercare Platform - Advanced Web Client.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171361
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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