510(k) · Cleared
ClearedVisi Mobile Monitioring 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 Dec 18, 2013 as substantially equivalent to K122036 (Sotera Wireless, Inc., 2012) after a 27-day review. Its family tree reaches back 9 generations to 1997. 18 later devices descend from it.
- Decided
- Dec 18, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962603 (1997). 36 ancestors in all, the oldest K872291 (1987). 18 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 1 generation backK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- This deviceK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- Descendant · cites it directly · 17 of its ownK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK150361 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK152341 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 4 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 1 generation backK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- This deviceK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · cites it directly17descendants
- K150992Vios Monitoring SystemVios Medical, Inc. · 2015 · 2 generations on7descendants
- K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 2 generations on6descendants
- K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019 · 3 generations on4descendants
- K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −4 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −3 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −2 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −1 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| 0 (this device) | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| +1 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +2 | K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015 | — |
| +2 | K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +3 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019 | — |
| +2 | K152341 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
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 |
|---|---|---|
| 2015 | 4 | 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? (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 |
|---|---|---|---|
| * | K122036 | Visi Mobile Monitoring SystemSummary page 1…umber 21 CFR 870.2300 Product code MWI, DRT, DXN, OQA, FILL Regulatory class If Predicate devices ViSi Mobile Monitoring System; K 122036 (Clearance: 8/18/2012) Description The ViSi Mobile Monitoring System is a lightweight, portable patient vital sig… | 2012 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143751 | Visi Mobile Monitoring System | 2015 | 17 |
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?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 8 of the 36 ancestors have a recall of any class.
- Of its descendants, K143751 (Sotera Wireless, Inc., 2015) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K122036.
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. 2013, 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 (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.
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/K133586 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133586: Visi Mobile Monitioring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133586
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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