510(k) · Cleared
ClearedWitt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Witt Biomedical Corporation · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Mar 13, 1998 after a 182-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 13, 1998
- Review
- 182 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to monitor, store and display patient data. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. The Wit Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including coronary care, post anesthesia recovery…
Read the full statement (184 words)
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to monitor, store and display patient data. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. The Wit Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including coronary care, post anesthesia recovery, operating room, critical care, surgical intensive care, respiratory intensive care, medical intensive care, pediatric intensive care, neonatal intensive care and patient holding areas of health care facilities. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Unit offers a thorough list of monitoring parameters which use proven algorithms of the Witt Biomedical Series IV. Patient information is displayed in a logical, easily understood format that requires minimal training. Operation parallels the Witt Series IV, affording familiarity to the users of any Witt Biomedical system.
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended for use by physicians, physician assistants, registered nurses, or other qualified hospital personnel with training on the operation of this equipment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973474 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973474: Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973474
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)
- Page last updated Nov 3, 2026