510(k) · Cleared
ClearedEmbraceMini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empatica S.r.l. · LEL Device, Sleep Assessment
Cleared on Dec 22, 2025 as substantially equivalent to K230457 (Empatica S.r.l., 2023) after a 96-day review. Its family tree reaches back 40 generations to 1994. 2 of the 416 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Dec 22, 2025
- Review
- 96 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 40 generations to K941811 (1994). 414 ancestors in all, the oldest K822695 (1982). 1 later device descends from it, 1 citing it directly. 2 of the 416 devices in this family, counting this one, have a Class I recall.
- Root · 40 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 36 generations between
- 3 generations backK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- 2 generations backK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
- 1 generation backK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023
- This deviceK252981 EmbraceMiniEmpatica S.r.l. · 2025
- Descendant · cites it directly · 0 of its ownK260374 Empatica Health Monitoring Platform for Parkinson's Disease…Empatica S.r.l. · 2026
Show all 40 generations
- Root · 40 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 39 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 38 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 37 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 36 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 35 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 34 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 33 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 32 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 31 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 30 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 29 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 28 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 27 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 26 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 25 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 24 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 23 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 22 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 21 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 20 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 19 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 18 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 17 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 16 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 15 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 14 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 13 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 12 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 11 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 10 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- 9 generations backK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- 8 generations backK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- 7 generations backK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- 6 generations backK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
- 5 generations backK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
- 4 generations backK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019
- 3 generations backK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- 2 generations backK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
- 1 generation backK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023
- This deviceK252981 EmbraceMiniEmpatica S.r.l. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −40 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −39 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −38 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −37 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −36 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −35 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −34 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −33 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −32 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −31 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −30 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −29 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −28 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −27 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −26 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −25 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −24 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −23 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −22 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −21 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −20 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −19 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −18 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −17 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −16 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −15 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −14 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −13 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −12 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −11 | K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −10 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
| −9 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| −8 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| −7 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| −6 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | — |
| −5 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… | Snap40, Ltd. | 2018 | — |
| −4 | 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 | — |
| −2 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
| −1 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | — |
| 0 (this device) | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | — |
| +1 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring… | Empatica S.r.l. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1989 | 6 | 0 |
| 1990 | 8 | 0 |
| 1991 | 11 | 0 |
| 1992 | 10 | 0 |
| 1993 | 7 | 0 |
| 1994 | 5 | 0 |
| 1995 | 11 | 0 |
| 1996 | 10 | 0 |
| 1997 | 14 | 1 |
| 1998 | 23 | 0 |
| 1999 | 18 | 0 |
| 2000 | 32 | 0 |
| 2001 | 17 | 0 |
| 2002 | 26 | 0 |
| 2003 | 19 | 1 |
| 2004 | 32 | 0 |
| 2005 | 25 | 0 |
| 2006 | 20 | 0 |
| 2007 | 11 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 13 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have a Class I recall. 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 LEL device
- #1 K243513 DCM (PW-DCM)score 11.0 · 7 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 |
|---|---|---|---|
| * | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalSummary page 6…Device Code(s) Number Primary Empatica Health Empatica MWI K230457 Monitoring Platform S.r.l. DQA… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | 2026 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 31 years and passes through 12 companies; a new generation was cleared every 4 months on median.
- 60 of the 414 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K260374 (Empatica S.r.l., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K230457.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LEL
3in 2025
2007high 3 (2025) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LEL
96in 2025
2007high 96 (2025)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LEL
No recall names LEL since 2007.
Adverse event reports per year · LEL
1in 2021
2007high 3 (2018) · low 0 (2008)2025
MAUDE reports naming product code LEL, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 96 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments.
The device supports continuous data collection for monitoring the following physiological parameters:
● Physical movement associated with applications in physiological monitoring
● Activity associated with movement during sleep
EmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252981: EmbraceMini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252981
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