510(k) · Cleared
Recalled · Class II · 2013Visi Mobile Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sotera Wireless, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Mar 22, 2012 as substantially equivalent to K043517 (Nihon Kohden America, Inc., 2005) and 1 other predicate after a 206-day review. Its family tree reaches back 5 generations to 1987. 24 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 22, 2012
- Review
- 206 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K872291 (1987). 10 ancestors in all. 24 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 4 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 3 generations backK022537 Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002
- 2 generations backK071645 Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007
- 1 generation backK082812 Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008
- This deviceK112478 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012
- Descendant · cites it directly · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · cites it directly · 19 of its ownK130709 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013
- Descendant · 2 generations on · 18 of its ownK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- Descendant · 2 generations on · 17 of its ownK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · cites it directly20descendants
- K130709Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013 · cites it directly19descendants
- K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · 2 generations on18descendants
- K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 2 generations on17descendants
- K150992Vios Monitoring SystemVios Medical, Inc. · 2015 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −4 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −3 | K022537 | Press-Mate PM-2100 Vital Sign Monitor | Colin Medical Instruments Corp. | 2002 | — |
| −2 | K071645 | Model HBP T-105 Series, Model T-105 and T-105S | Omron Healthcare, Inc. | 2007 | — |
| −1 | K082812 | Omron Model HBP-2070 Vital Signs Monitor | Omron Healthcare, Inc. | 2008 | — |
| 0 (this device) | K112478 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | — |
| +1 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +1 | K130709 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2013 | — |
| +2 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| +2 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +3 | K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 6 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K043517 | Transmitter, ZS-940PA SeriesSummary page 1…(without arrhythmia detection or alarms: 21 CFR 870.2300 (MWI) Predicate device Nihon Kobden ZS-940PA K043517, Clearance date: Febmuary 3, 2005 Omron Healthcare, Inc.. HBP-2070 K0828… | 2005 |
| * | K082812 | Omron Model HBP-2070 Vital Signs MonitorSummary page 1…n ZS-940PA K043517, Clearance date: Febmuary 3, 2005 Omron Healthcare, Inc.. HBP-2070 K0828 12, Clearance date: October 22, 2008 Description The ViSi Mobile Monitoring System is a lightweight, portable patie… | 2008 |
What descends from it? (24)
See all 243 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2013 | Class II | Z-1818-2013 | Device Design | Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound. |
| May 23, 2013 | Class II | Z-1817-2013 | Device Design | Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K122036 (Sotera Wireless, Inc., 2012) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K043517.
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. 2012, 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 ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. It is indicated for EGG (3 or 5 leadwire), respiration rate (RESP), heart rate (H-R), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112478 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112478: Visi Mobile Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112478
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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