510(k) · Cleared
ClearedVisensia, Visensia with Alert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obs Medical · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 15, 2011 as substantially equivalent to K081140 (Obs Medical, 2008) after a 71-day review. Its family tree reaches back 7 generations to 1997. 17 later devices descend from it.
- Decided
- Jun 15, 2011
- Review
- 71 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962603 (1997). 35 ancestors in all, the oldest K891104 (1989). 17 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 2 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 1 generation backK081140 VisensiaObs Medical · 2008
- This deviceK110953 Visensia, Visensia with AlertObs Medical · 2011
- Descendant · cites it directly · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · 2 generations on · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
- Descendant · 3 generations on · 14 of its ownK190273 T3 Platform softwareEtiometry, Inc. · 2019
- Descendant · 4 generations on · 13 of its ownK202306 T3 Platform softwareEtiometry, Inc. · 2020
- Descendant · 5 generations on · 12 of its ownK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K152258T3 SoftwareEtiometry, Inc. · 2016 · cites it directly16descendants
- K163065T3 SoftwareEtiometry, Inc. · 2017 · 2 generations on15descendants
- K190273T3 Platform softwareEtiometry, Inc. · 2019 · 3 generations on14descendants
- K202306T3 Platform softwareEtiometry, Inc. · 2020 · 4 generations on13descendants
- K213230T3 Platform SoftwareEtiometry, Inc. · 2022 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −2 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −1 | K081140 | Visensia | Obs Medical | 2008 | — |
| 0 (this device) | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| +1 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +2 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| +3 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| +4 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| +5 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K081140 | VisensiaSummary page 2…Device: Visensia® Data Supporting with Alert Device Change K081140 K110953 Intended Visensia® with alert is an Indication/Intended Use of the… | 2008 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152258 | T3 Software | 2016 | 16 |
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 14 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 35 ancestors have a recall of any class.
- Of its descendants, K152258 (Etiometry, Inc., 2016) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K081140.
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. 2011, this device’s year, is highlighted.
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?
Visensia® With alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. Visensia® provides the clinician wit a patient status index (Visensia® Index) based on a weighted average of five or (four) vital signs…
Read the full statement (143 words)
Visensia® With alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
Visensia® provides the clinician wit a patient status index (Visensia® Index) based on a weighted average of five or (four) vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia@ is an adjunct to and is not intended to replace vital sign monitoring.
When a Visensia® alert has activated, it means that the Visensia® Index has reached and/or surpassed the default ihreshold and indicates that attention should be brought to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110953: Visensia, Visensia with Alert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110953
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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