510(k) · Cleared
ClearedTablet Commander
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocom, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Aug 14, 2012 as substantially equivalent to K053304 (Cardiocom, LLC, 2005) and 2 other predicates after a 15-day review. Its family tree reaches back 15 generations to 1987. 5 later devices descend from it.
- Decided
- Aug 14, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K864318 (1987). 61 ancestors in all, the oldest K790130 (1979). 5 later devices descend from it, 2 citing it directly.
- 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 deviceK122285 Tablet CommanderCardiocom, LLC · 2012
- Descendant · cites it directly · 3 of its ownK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- Descendant · 3 generations on · 1 of its ownK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- Descendant · 3 generations on · 0 of its ownK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK191745 Medtronic Commander FlexMedtronic Care Management Services · 2020
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 deviceK122285 Tablet CommanderCardiocom, LLC · 2012
Most influential descendants
Showing 5 of 5 · See all- K133252Healthinterlink BeaconHealthinterlink, LLC · 2014 · cites it directly3descendants
- K181248Comarch e-Care PlatformComarch Healthcare SA · 2018 · 2 generations on2descendants
- K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022 · 3 generations on1descendant
- K252440EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025 · 3 generations on0descendants
- K191745Medtronic Commander FlexMedtronic Care Management Services · 2020 · cites it directly0descendants
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) | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| +1 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| +2 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| +3 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
| +3 | K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025 | — |
| +1 | K191745 | Medtronic Commander Flex | Medtronic Care Management Services | 2020 | — |
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 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K053304 | Commander Iii Non-Invasive Blood Pressure SystemSummary page 1…Class: IT Product Code: DRG Predicate Device(s): The subject device is equivalent to the following devices: Cardiocom Commander [II, K053304; Intel Health Guide Express, K 103276; Hormned Genesis Touch, KI 112858 Device Description: The Tablet… | 2005 |
| * | K103276 | Intel Health GuideSummary page 1…The subject device is equivalent to the following devices: Cardiocom Commander [II, K053304; Intel Health Guide Express, K 103276; Hormned Genesis Touch, KI 112858 Device Description: The Tablet Commander is a software application. Once installed on… | 2011 |
| * | K112858 | Genesis Touch SystemSummary page 1…to the following devices: Cardiocom Commander [II, K053304; Intel Health Guide Express, K 103276; Hormned Genesis Touch, KI 112858 Device Description: The Tablet Commander is a software application. Once installed on a commercially-a… | 2012 |
What descends from it? (5)
2 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 25 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 61 ancestors have a recall of any class.
- Of its descendants, K133252 (Healthinterlink, LLC, 2014) has gone furthest, with 3 descendants of its own.
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. 2012, 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 Tablet Commander device is for use by patients to collect and transmit general health information, physiological measurements and other data between themselves and a caregiver.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122285: Tablet Commander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122285
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