510(k) · Cleared
ClearedThe Hermes System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palaistra Systems, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 20, 2005 as substantially equivalent to K041816 (Rtx Healthcare A/S, 2004) and 1 other predicate after a 36-day review. Its family tree reaches back 7 generations to 1987. 45 later devices descend from it.
- Decided
- May 20, 2005
- Review
- 36 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K864318 (1987). 19 ancestors in all, the oldest K790130 (1979). 45 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 5 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 4 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 3 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 2 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 1 generation backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- This deviceK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- Descendant · cites it directly · 35 of its ownK062215 Confidant 2.0Confidant, Inc. · 2006
- Descendant · 2 generations on · 34 of its ownK072698 Confidant 2.5Confidant, Inc. · 2007
- Descendant · cites it directly · 20 of its ownK062377 Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 3 generations on · 9 of its ownK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K062215Confidant 2.0Confidant, Inc. · 2006 · cites it directly35descendants
- K072698Confidant 2.5Confidant, Inc. · 2007 · 2 generations on34descendants
- K062377Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007 · cites it directly20descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 2 generations on12descendants
- K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −6 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −5 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −4 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −3 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −2 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −1 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| 0 (this device) | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| +1 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| +2 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| +1 | K062377 | Medapps Remote Patient Monitoring, Model MA 100 | Medapps, Inc. | 2007 | — |
| +2 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +3 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 11 | 0 |
| 2014 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K041816 | RTX3320PSTN Wireless Telehealth GatewaySummary page 1…vices Palaistra Systems Inc. believes the Hermes System is substantially equivalent to the following legally marketed devices: · Telehealth Gateway: K041816 (DRG) * Carematix: K040966 (DXN and DRG) 3 Description of the device The Hermes System is an accessory device tha… | 2004 |
| * | K040966 | Modification to Carematix Wellness SystemSummary page 1…eves the Hermes System is substantially equivalent to the following legally marketed devices: · Telehealth Gateway: K041816 (DRG) * Carematix: K040966 (DXN and DRG) 3 Description of the device The Hermes System is an accessory device that collects data from a range of s… | 2004 |
What descends from it? (45)
See all 453 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 18 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K062215 (Confidant, Inc., 2006) has gone furthest, with 35 descendants of its own.
- 4 other devices also cite its predicate K041816.
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.
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 Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare…
Read the full statement (316 words)
The Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider.
The Hermes System is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient.
Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone and provides the data collection, transmission and message display capabilities. The Server module is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the set-up. data management, and message delivery capabilities.
Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hernias can send email to the patient's doctor and/or guardian if good habits are not maintained.
The Hermes System is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
Hermes is not intended to provide automated treatment decisions, nor to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050929: The Hermes System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050929
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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