510(k) · Cleared
ClearedVerizon Wireless Converged Health Management Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cellco Partnership D/B/A Verizon Wireless · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Feb 14, 2014 as substantially equivalent to K122458 (Cello Partnership D/B/A Verizon Wireless, 2013) after a 49-day review. Its family tree reaches back 13 generations to 1987.
- Decided
- Feb 14, 2014
- Review
- 49 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K864318 (1987). 27 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations between
- 3 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 2 generations backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- 1 generation backK122458 Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013
- This deviceK134004 Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless · 2014
Show all 13 generations
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 6 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 5 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 4 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 3 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 2 generations backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- 1 generation backK122458 Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013
- This deviceK134004 Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −12 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −11 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −10 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −9 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −8 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −7 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −6 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −5 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −4 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| −3 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| −2 | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| −1 | K122458 | Verizon Wireless Remote Health Management System | Cello Partnership D/B/A Verizon Wireless | 2013 | — |
| 0 (this device) | K134004 | Verizon Wireless Converged Health Management Device | Cellco Partnership D/B/A Verizon Wireless | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K122458 | Verizon Wireless Remote Health Management SystemSummary page 1…ation Name: Radiofrequency Physiological Signal Transmitter and Receiver Predicate Devices: The Verizon Wireless Converged Health Management Device isa modification to K122458 Verizon Wireless Converged Health Management Device.… | 2013 |
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 12 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K122458.
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 CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via an existing mobile telecommunications and/or internet infrastructure. The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also…
Read the full statement (159 words)
The CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via an existing mobile telecommunications and/or internet infrastructure.
The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational and motivational content from clinicians.
The CHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor.
The CHM Device is not intended for use in surgical rooms, intensive care units, intermediate or step-down units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals. It does not provide real-time or emergency monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134004: Verizon Wireless Converged Health Management Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134004
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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