510(k) · Cleared
ClearedIntel-GE Care Innovations Connect RCM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intel-Ge Care Innovations, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Aug 9, 2013 as substantially equivalent to K130290 (Intel-Ge Care Innovations, LLC, 2013) and 2 other predicates after a 137-day review. Its family tree reaches back 16 generations to 1987.
- Decided
- Aug 9, 2013
- Review
- 137 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K864318 (1987). 64 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations between
- 3 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 2 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 1 generation backK130290 Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC · 2013
- This deviceK130821 Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC · 2013
Show all 16 generations
- Root · 16 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 15 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 14 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 13 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 12 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 11 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 10 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 9 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 8 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 7 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 6 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 5 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 4 generations backK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- 3 generations backK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- 2 generations backK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
- 1 generation backK130290 Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC · 2013
- This deviceK130821 Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −15 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −14 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −13 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −12 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −11 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −10 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −9 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −8 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −7 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −6 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −5 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −4 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| −3 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| −2 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
| −1 | K130290 | Modification to Intel-GE Care Iinovations Guide | Intel-Ge Care Innovations, LLC | 2013 | — |
| 0 (this device) | K130821 | Intel-GE Care Innovations Connect RCM | Intel-Ge Care Innovations, LLC | 2013 | — |
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 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 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? (3)
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 |
|---|---|---|---|
| * | K130290 | Modification to Intel-GE Care Iinovations Guide Cleared while this submission was under review Summary page 1…y (21 CFR 870.2910, Product Code DRG) Substantial Equivalence of intended use is claimed to the following Over the Counter devices: 1. Intel-GE Care Innovations Guide (K130290) 2. Wellaho Personalized Outpatient Management System (K123671) 3. Vignet Telehealth Manager (K1 13446) Device Description Care… | 2013 |
| * | K123671 | Wellaho Personalized Outpatient Management SystemSummary page 1…of intended use is claimed to the following Over the Counter devices: 1. Intel-GE Care Innovations Guide (K130290) 2. Wellaho Personalized Outpatient Management System (K123671) 3. Vignet Telehealth Manager (K1 13446) Device Description Care Innovations TMConnect RCM is a software application for use wit… | 2013 |
| * | K113446 | Vignet Telehealth ManagerSummary page 1…wing Over the Counter devices: 1. Intel-GE Care Innovations Guide (K130290) 2. Wellaho Personalized Outpatient Management System (K123671) 3. Vignet Telehealth Manager (K1 13446) Device Description Care Innovations TMConnect RCM is a software application for use with measurement devices commercially avail… | 2012 |
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 26 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 64 ancestors have a recall of any class.
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. 2013, 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?
Intel-GE Care Innovations Connect RCM 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. Patients can also engage in videoconferences with caregivers and answer the caregivers' questions by participating in surveys. Care Innovations Connect RCM is not…
Read the full statement (155 words)
Intel-GE Care Innovations Connect RCM 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. Patients can also engage in videoconferences with caregivers and answer the caregivers' questions by participating in surveys.
Care Innovations Connect RCM 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.
Care Innovations Connect RCM 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.
Care Innovations Connect RCM will be available for over the Counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130821: Intel-GE Care Innovations Connect RCM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130821
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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