510(k) · Cleared
ClearedWAVE Clinical Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel Medical Electronics, LLC · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 4, 2018 as substantially equivalent to K140339 (Covidien, 2014) after a 269-day review. Its family tree reaches back 4 generations to 2012. 1 later device descends from it.
- Decided
- Jan 4, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K122133 (2012). 5 ancestors in all, the oldest K091461 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK122133 Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 2012
- 3 generations backK130796 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- 2 generations backK132604 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- 1 generation backK140339 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · Recalled
- This deviceK171056 WAVE Clinical PlatformExcel Medical Electronics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK250135 WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical · 2026
Most influential descendants
Showing 1 of 1 · See all- K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing | Airstrip Technologies, LP | 2012 | — |
| −3 | K130796 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| −2 | K132604 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| −1 | K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2014 | 2 |
| 0 (this device) | K171056 | WAVE Clinical Platform | Excel Medical Electronics, LLC | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformSummary page 5…Diagnostic Computer 5. PREDICATE DEVICE: COVIDIEN VITAL SYNC™ INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM (K140339; MWI, OUG) INTENDED USE: "The Vital Sync™ Informatics Manager is software that is intended to route and store… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250135 | WAVE Clinical Platform (2.0.000) | 2026 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K250135 (Baxter Healthcare Corp/ Excel Medical, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K140339.
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 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 physiologic data, waveforms, alarms, results and diagnostic information routed through the WAVE Clinical Platform from supported devices and systems. The WAVE…
Read the full statement (164 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 physiologic data, waveforms, alarms, results and diagnostic information routed through the WAVE Clinical Platform from supported devices and systems. The WAVE Clinical Platform is intended for use in hospital or hospital type environments. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes:
* To remotely consult regarding patients’ statuses;
* To remotely review other standard or critical near real-time patient data, waveforms, alarms, and results in order to utilize this information to aid in clinical decisions.
Warning: The WAVE Clinical Platform is intended to supplement and not to 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/K171056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171056: WAVE Clinical Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171056
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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