510(k) · Cleared
ClearedVerizon Wireless Remote Health Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cello Partnership D/B/A Verizon Wireless · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 30, 2013 as substantially equivalent to K092635 (Alcatel-Lucent Canada, Inc., 2009) and 1 other predicate after a 351-day review. Its family tree reaches back 12 generations to 1987. 2 later devices descend from it.
- Decided
- Jul 30, 2013
- Review
- 351 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K864318 (1987). 26 ancestors in all, the oldest K790130 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations between
- 3 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 2 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 1 generation backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- This deviceK122458 Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013
- Descendant · cites it directly · 0 of its ownK132930 Myhealthpoint Telehealth ManagerEntra Health Systems · 2014
- Descendant · cites it directly · 0 of its ownK134004 Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless · 2014
Show all 12 generations
- Root · 12 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 11 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 10 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 9 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 8 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 7 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 6 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 5 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 4 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 3 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 2 generations backK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
- 1 generation backK113446 Vignet Telehealth ManagerVignet, Inc. · 2012
- This deviceK122458 Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −11 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −10 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −9 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −8 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −7 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −6 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −5 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −4 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −3 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| −2 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
| −1 | K113446 | Vignet Telehealth Manager | Vignet, Inc. | 2012 | — |
| 0 (this device) | K122458 | Verizon Wireless Remote Health Management System | Cello Partnership D/B/A Verizon Wireless | 2013 | — |
| +1 | K132930 | Myhealthpoint Telehealth Manager | Entra Health Systems | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K092635 | Alcatel-Lucent Teleheath ManagerSummary page 1…tem Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver (21 CFR 870.2910; DRG) Predicate Devices: Alcatel-Lucent Telehealth Manager (K092635) Vignet Telehealth Monitoring System (K1 13446) Intended Use / Indications for Use The CHM Device is a remote monitoring soft… | 2009 |
| * | K113446 | Vignet Telehealth ManagerSummary page 1…ogical Signal Transmitter and Receiver (21 CFR 870.2910; DRG) Predicate Devices: Alcatel-Lucent Telehealth Manager (K092635) Vignet Telehealth Monitoring System (K1 13446) Intended Use / Indications for Use The CHM Device is a remote monitoring software solution intended to collect and store biomne… | 2012 |
What descends from it? (2)
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 26 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K132930 (Entra Health Systems, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092635.
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?
The OHM 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 existing mobile telecommunications and/or Internet infrastructure. The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review…
Read the full statement (158 words)
The OHM 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 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 OHM 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 OHM 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/K122458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122458: Verizon Wireless Remote Health Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122458
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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