510(k) · Cleared
ClearedSickbay Clinical Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Informatics Corp · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 26, 2015 as substantially equivalent to K132604 (Covidien, 2013) after a 189-day review. Its family tree reaches back 3 generations to 2012.
- Decided
- May 26, 2015
- Review
- 189 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K122133 (2012). No later device cites it as a predicate yet.
- Root · 3 generations backK122133 Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 2012
- 2 generations backK130796 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- 1 generation backK132604 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- This deviceK143304 Sickbay Clinical PlatformMedical Informatics Corp · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing | Airstrip Technologies, LP | 2012 | — |
| −2 | K130796 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| −1 | K132604 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| 0 (this device) | K143304 | Sickbay Clinical Platform | Medical Informatics Corp | 2015 | — |
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 |
|---|---|---|---|
| * | K132604 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformSummary page 4…nostic computer. PREDICATE DEVICE: COVIDIEN VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM - 510(k)’s: K132604 6500 Main Street 1020G BioScience Research Collaborative Houston TX 77030… | 2013 |
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 3 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K132604.
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. 2015, 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 Sickbay Clinical Platform is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (EMR) and Clinical Information Systems. The Sickbay Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Sickbay Clinical Platform for supported devices. The Sickbay Clinical Platform is intended to be…
Read the full statement (155 words)
The Sickbay Clinical Platform is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (EMR) and Clinical Information Systems.
The Sickbay Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Sickbay Clinical Platform for supported devices. The Sickbay Clinical Platform is intended to be used by healthcare professionals in a hospital setting for the following purposes:
x To remotely consult, regarding a patient's status
x To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
WARNING: The Sickbay Clinical Platform is intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Sickbay Clinical Platform product as the sole source of alarms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143304 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143304: Sickbay Clinical Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143304
Report an extraction error
Are you the manufacturer?
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