510(k) · Cleared
ClearedCalysto Series IV Physio-Monitoring and Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Witt Biomedical Corp · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Dec 21, 2006 as substantially equivalent to K033030 (Witt Biomedical Corp, 2004) after a 27-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Dec 21, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033030 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK033030 Calysto Series IV Patient Care Monitors and Central Station and Ecg…Witt Biomedical Corp · 2004 · Recalled
- This deviceK063547 Calysto Series IV Physio-Monitoring and Information SystemWitt Biomedical Corp · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033030 | Calysto Series IV Patient Care Monitors and Central Station and Ecg Management… | Witt Biomedical Corp | 2004 | 1 |
| 0 (this device) | K063547 | Calysto Series IV Physio-Monitoring and Information System | Witt Biomedical Corp | 2006 | — |
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 |
|---|---|---|---|
| * | K033030 | Calysto Series IV Patient Care Monitors and Central Station and Ecg Management SystemSummary page 1…alarms) Class 11 Predicate Device: CALYSTO Series IV, Patient Care Monitor and Central Station System K033030 Device Description: The modified device has the same intended use as the legally marketed pre… | 2004 |
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 a recall.
- 1 other device also cites its predicate K033030.
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.
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 CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations…
Read the full statement (177 words)
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or intermet, or may function as a stand-alone device.
Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.
Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063547: Calysto Series IV Physio-Monitoring and Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063547
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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