510(k) · Cleared
ClearedModification to Flexview Clinical Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Data Critical Corp. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jul 24, 2001 as substantially equivalent to K003998 (Data Critical Corp., 2001) after a 27-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 24, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003998 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003998 Flexview Clinical Monitoring SystemData Critical Corp. · 2001
- This deviceK011999 Modification to Flexview Clinical Monitoring SystemData Critical Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003998 | Flexview Clinical Monitoring System | Data Critical Corp. | 2001 | — |
| 0 (this device) | K011999 | Modification to Flexview Clinical Monitoring System | Data Critical Corp. | 2001 | — |
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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K003998 | Flexview Clinical Monitoring SystemSummary page 1…Classification Name: System, Network and Communication, Physiological Monitors Device Ciassification: Ciass ii Predicate Device(s): FlexView™ Clinical Monitoring System (K003998) Device Descripiion The FlexView™ Clinical Monitoring System is a PC based central monitoring station used to acquire informati… | 2001 |
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.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms. The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with pulse oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure. The…
Read the full statement (155 words)
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.
The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with pulse oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.
The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the use of the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician’s care.
The FlexView™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.
The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, outpatient clinics or free standing surgical centers.
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/K011999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011999: Modification to Flexview Clinical Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011999
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026