510(k) · Cleared
ClearedWAVE Clinical Platform (2.0.000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp/ Excel Medical · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 16, 2026 as substantially equivalent to K171056 (Excel Medical Electronics, LLC, 2018) after a 364-day review. Its family tree reaches back 5 generations to 2012.
- Decided
- Jan 16, 2026
- Review
- 364 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K122133 (2012). 6 ancestors in all, the oldest K091461 (2009). No later device cites it as a predicate yet.
- Root · 5 generations backK122133 Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 2012
- 4 generations backK130796 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- 3 generations backK132604 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- 2 generations backK140339 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · Recalled
- 1 generation backK171056 WAVE Clinical PlatformExcel Medical Electronics, LLC · 2018
- This deviceK250135 WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing | Airstrip Technologies, LP | 2012 | — |
| −4 | K130796 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| −3 | K132604 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| −2 | K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2014 | 2 |
| −1 | K171056 | WAVE Clinical Platform | Excel Medical Electronics, LLC | 2018 | — |
| 0 (this device) | K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 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 |
|---|---|---|---|
| * | K171056 | WAVE Clinical PlatformSummary page 6…e Device(s) Device Company Predicate 510(k) Clearance Date Version 1.0 WAVE EXCEL Medical K171056 January 2018 Clinical Platform DESCRIPTION OF THE DEVICE: The WAVE Clinical Platform is a remote monitor… | 2018 |
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 14 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 3 of the 6 ancestors have a recall of any class.
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. 2026, 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 WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS). The WAVE Clinical Platform is a remote monitoring platform that displays physiological data, waveforms, alarms, results, diagnostic and operational information routed through the platform from devices and systems using supported…
Read the full statement (170 words)
The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS). The WAVE Clinical Platform is a remote monitoring platform that displays physiological data, waveforms, alarms, results, diagnostic and operational information routed through the platform from devices and systems using supported protocols. The WAVE Clinical Platform is intended for use in hospital and hospital type environments or where clinical consultations are needed. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes:
» To remotely consult regarding patients’ conditions and statuses;
* To remotely review other standard or critical patient and operational data, waveforms, alarms, and results to utilize this information to aid in clinical decisions.
Warning: The WAVE Clinical Platform is intended to supplement and not replace any part of the hospital's device monitoring or electronic data management systems. Do not rely on the WAVE Clinical Platform product as the sole source of alarms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250135: WAVE Clinical Platform (2.0.000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250135
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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