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 Aug 15, 2012 as substantially equivalent to K112478 (Sotera Wireless, Inc., 2012) and 3 other predicates after a 35-day review. Its family tree reaches back 8 generations to 1997. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 15, 2012
- Review
- 35 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962603 (1997). 35 ancestors in all, the oldest K872291 (1987). 20 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 3 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 2 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 1 generation backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- This deviceK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 6 of its ownK150361 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · cites it directly18descendants
- K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 2 generations on17descendants
- K150992Vios Monitoring SystemVios Medical, Inc. · 2015 · 3 generations on7descendants
- K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 3 generations on6descendants
- K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −2 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −1 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| 0 (this device) | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | — |
| +1 | 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 | — |
| +3 | K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +4 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K112478 | Visi Mobile Monitoring System | 2012 |
| * | K033378 | Vital Signs Monitor, Propaq LTSummary page 1…MWI, DRT, DXN, DQA and FLL Predicate device ViSi Mobile Monitoring System (KI 12478) Propaq LT VSM, Model 802 Series (K033378) Micropaq VSM, Models 402, 404 (K002725) Acuity Central Monitor… | 2004 |
| * | K002725 | Micropaq, Models 402 and 404Summary page 1…e Monitoring System (KI 12478) Propaq LT VSM, Model 802 Series (K033378) Micropaq VSM, Models 402, 404 (K002725) Acuity Central Monitoring Station Predicate (K022453) Description The ViS… | 2000 |
| * | K022453 | Modification to Acuity Central Monitoring SystemSummary page 1…2 Series (K033378) Micropaq VSM, Models 402, 404 (K002725) Acuity Central Monitoring Station Predicate (K022453) Description The ViSi Mobile Monitoring System is a lightweight, portable patient vital… | 2002 |
What descends from it? (20)
See all 202 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 15 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 7 of the 35 ancestors have a recall of any class.
- Of its descendants, K133586 (Sotera Wireless, Inc., 2013) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K112478.
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 ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIEP), 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.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to central station through wireless 802.11 communication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122036: Visi Mobile 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/K122036
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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