510(k) · Cleared
ClearedLG Smarthealth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lg Electronics · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 21, 2014 as substantially equivalent to K103276 (Intel Corporation Digital Health Group, 2011) after a 329-day review. Its family tree reaches back 15 generations to 1987.
- Decided
- Nov 21, 2014
- Review
- 329 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K864318 (1987). 54 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 11 generations between
- 3 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 2 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 1 generation backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- This deviceK133997 LG SmarthealthLg Electronics · 2014
Show all 15 generations
- Root · 15 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 14 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 13 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 12 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 11 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 10 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 9 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 8 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 7 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 6 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 5 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 4 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 3 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 2 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 1 generation backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- This deviceK133997 LG SmarthealthLg Electronics · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −14 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −13 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −12 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −11 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −10 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −9 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −8 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −7 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −6 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −5 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −4 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −3 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −2 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −1 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| 0 (this device) | K133997 | LG Smarthealth | Lg Electronics | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K103276 | Intel Health GuideSummary page 5…Code DRG Device Class: Class II Classification Panel: Cardiovascular 5. Legally Marketed Predicate Device(s) Intel Health Guide Express (K103276) Page 5‐1 6. Device Description The LG SmartHealth application… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 54 ancestors have a recall of any class.
- 5 other devices also cite its predicate K103276.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The LG SmartHealth is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers(or nurse). Patients can also engage in video conferences with caregivers(or nurse). The LG SmartHealth is not interpretive, nor is it intended for diagnosis or as a substitute for medical…
Read the full statement (132 words)
The LG SmartHealth is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers(or nurse). Patients can also engage in video conferences with caregivers(or nurse).
The LG SmartHealth is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The LG SmartHealth is contraindicated for patients requiring direct-medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133997: LG Smarthealth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133997
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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