510(k) · Cleared
ClearedVisensia
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 Jul 17, 2008 as substantially equivalent to K030267 (Aspect Medical Systems, Inc., 2004) and 3 other predicates after an 86-day review. Its family tree reaches back 6 generations to 1997. 22 later devices descend from it.
- Decided
- Jul 17, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962603 (1997). 34 ancestors in all, the oldest K891104 (1989). 22 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 1 generation backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- This deviceK081140 VisensiaObs Medical · 2008
- Descendant · cites it directly · 17 of its ownK110953 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
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K110953Visensia, Visensia with AlertObs Medical · 2011 · cites it directly17descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −1 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| 0 (this device) | K081140 | Visensia | Obs Medical | 2008 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K030267 | Eeg Monitor with Bis, Model a-2000Summary page 2…sensia is substantially equivalent to the following devices: ® Predicate device: A-2000 EEG Monitor with BIS Company: Aspect Medical Systems 510(K) Number: K030267 A-2000 EEG Monitor with BIS is an EEG monitoring system that monitors the state of the brain of an anesthetized or sedated pati… | 2004 |
| * | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Summary page 2…graph indicative of the patient's state. Predicate device: Propaq 200 Series multi-parameter physiological monitor Company: Welch Allyn Protocol, Inc 510(K) Number: K012451 Visensia is a software accessory to multi-parameter physiological patient monitors and as such is substantially equivalent to t… | 2001 |
| * | K992607 | Sonicaid System 8002Summary page 3…51 OK Summary 2 Predicate device: Sonicaid System 8002 Company: Oxford Instruments Medical 510(K) Number: K992607 Sonicaid System 8002 is a software accessory for the computerized analysis of antepartum cardiotocograms (CTGs). It informs the c… | 2001 |
| * | K061993 | Equivital, Model EQ-01Summary page 3…ort to a clinician in the determination of normality based on a model derived from historic clinical data. Predicate device: EquivitalTM Company: Hidalgo 510(K) Number: K061993 The EquivitalTM device combines physiological parameters in to one index, "Physiological Welfare Index" and provides indications… | 2006 |
What descends from it? (22)
See all 223 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)
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 11 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K110953 (Obs Medical, 2011) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K030267.
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. 2008, 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-paediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or four vital signs…
Read the full statement (163 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-paediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
Visensia® provides the clinician with 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® with Alert is an adjunct to and is not intended to replace vital sign monitoring and as such does not contain alarms, but alerts the physician to changes in the patient's physiological status.
When a Visensia® Alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081140: Visensia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081140
Report an extraction error
Are you the manufacturer?
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