510(k) · Cleared
ClearedEquivital
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hidalgo Limited · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 17, 2012 as substantially equivalent to K061993 (Hidalgo Limited, 2006) and 6 other predicates after a 127-day review. Its family tree reaches back 6 generations to 1997. 71 later devices descend from it.
- Decided
- Feb 17, 2012
- Review
- 127 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K962603 (1997). 23 ancestors in all, the oldest K891104 (1989). 71 later devices descend from it, 1 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 deviceK113054 EquivitalHidalgo Limited · 2012
- Descendant · cites it directly · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- Descendant · 2 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- Descendant · 2 generations on · 18 of its ownK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019
- Descendant · 3 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 3 generations on · 15 of its ownK163255 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker…Caretaker Medical, LLC · 2017
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · cites it directly70descendants
- K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 2 generations on43descendants
- K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd. · 2019 · 2 generations on18descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 3 generations on16descendants
- K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC · 2017 · 3 generations on15descendants
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) | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +1 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| +2 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| +2 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in… | Current Health, Ltd. | 2019 | — |
| +3 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +3 | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless… | Caretaker Medical, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 11 | 0 |
| 2026 | 7 | 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? (7)
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 |
|---|---|---|---|
| * | K061993 | Equivital, Model EQ-01Summary page 2…hidalgoeee*o Predicate Devices The device has been compared to the following predicate: Hidalgo EQ01 K061993 Additional Predicates: GMP Wireless Medicine UifeSyn CTM - K030795 Dymedix Inc… | 2006 |
| * | K030795 | Lifesyne SystemsSummary page 2…EQ01 K061993 Additional Predicates: GMP Wireless Medicine UifeSyn CTM - K030795 Dymedix Inc Re-usable Respiratory Effort Belt Sensor - K040605 Nexan Inc NX-300… | 2003 |
| * | K040605 | Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb…Summary page 2…icates: GMP Wireless Medicine UifeSyn CTM - K030795 Dymedix Inc Re-usable Respiratory Effort Belt Sensor - K040605 Nexan Inc NX-300 - K003520 Protocol Systems Propaq Encor… | 2004 |
| * | K003520 | Nexan System, Model NX-300Summary page 2…K030795 Dymedix Inc Re-usable Respiratory Effort Belt Sensor - K040605 Nexan Inc NX-300 - K003520 Protocol Systems Propaq Encore 200 - K012451 Respronics Actiheart®… | 2000 |
| * | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Summary page 2…040605 Nexan Inc NX-300 - K003520 Protocol Systems Propaq Encore 200 - K012451 Respronics Actiheart® - K052489 Vivometrics Life Shirtrm… | 2001 |
| * | K052489 | ActiheartSummary page 2…003520 Protocol Systems Propaq Encore 200 - K012451 Respronics Actiheart® - K052489 Vivometrics Life Shirtrm Real Time -K043604 Device Description The Equivital TM Vital… | 2005 |
| * | K043604 | Lifeshirt Real-Time with Vivomonitor SoftwareSummary page 2…K012451 Respronics Actiheart® - K052489 Vivometrics Life Shirtrm Real Time -K043604 Device Description The Equivital TM Vital Signs Physiological monitor comprises two components: i) A chest belt containing ski… | 2005 |
What descends from it? (71)
See all 711 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and… | 2014 | 70 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K141167 (Vitalconnect, Inc., 2014) has gone furthest, with 70 descendants of its own.
- 2 other devices also cite its predicate K061993.
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. 2012, 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?
The EquivitaTM Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital care facilities, the home, workplace and alternate care settings.
The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt.
The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion.
The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113054: Equivital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113054
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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