510(k) · Cleared
ClearedRTX3320PSTN Wireless Telehealth Gateway
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rtx Healthcare A/S · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 19, 2004 as substantially equivalent to K023749 (Philips Medical Systems, 2002) after a 13-day review. Its family tree reaches back 5 generations to 1987. 59 later devices descend from it.
- Decided
- Jul 19, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K864318 (1987). 12 ancestors in all, the oldest K790130 (1979). 59 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 4 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 3 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 2 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 1 generation backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- This deviceK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
- Descendant · cites it directly · 45 of its ownK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- Descendant · 2 generations on · 35 of its ownK062215 Confidant 2.0Confidant, Inc. · 2006
- Descendant · 3 generations on · 34 of its ownK072698 Confidant 2.5Confidant, Inc. · 2007
- Descendant · cites it directly · 25 of its ownK052343 E-San Bluetooth CradleE-San Limited · 2005
- Descendant · 2 generations on · 24 of its ownK061328 Think Positive Diabetes Management System (T+Diabetes System)E-San Limited · 2006
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K050929The Hermes SystemPalaistra Systems, Inc. · 2005 · cites it directly45descendants
- K062215Confidant 2.0Confidant, Inc. · 2006 · 2 generations on35descendants
- K072698Confidant 2.5Confidant, Inc. · 2007 · 3 generations on34descendants
- K052343E-San Bluetooth CradleE-San Limited · 2005 · cites it directly25descendants
- K061328Think Positive Diabetes Management System (T+Diabetes System)E-San Limited · 2006 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −4 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −3 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −2 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −1 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| 0 (this device) | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
| +1 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| +2 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| +3 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| +1 | K052343 | E-San Bluetooth Cradle | E-San Limited | 2005 | — |
| +2 | K061328 | Think Positive Diabetes Management System (T+Diabetes System) | E-San Limited | 2006 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 2 | 0 |
| 2013 | 11 | 0 |
| 2014 | 4 | 0 |
| 2017 | 3 | 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? (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 |
|---|---|---|---|
| * | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Summary page 1…al Transmitter And Receiver. Classification no: DRG Predicate Device: The RTX3320 device is substantially equivalent to the following predicate device: 510(k) number: K023749 Device name: M3810A Philips Telemonitoring System with M3812B TeleStation. Applicant: Philips Medical Systems Submission Device… | 2002 |
| † | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | 2004 |
What descends from it? (59)
See all 595 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 17 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K050929 (Palaistra Systems, Inc., 2005) has gone furthest, with 45 descendants of its own.
- 9 other devices also cite its predicate K023749.
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 RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness…
Read the full statement (217 words)
The RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness provider or other out-of-hospital caregivers.
The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.
RTX3320 is a "black box" device - it is not connected to the patient and not operated by the patient. The installation must be performed by or under supervision of an authorized professional healthcare company.
This device does not measure, interpret or make any decisions on the vital data that it conveys.
Contraindications, precautions and warnings
This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data.
Clinical judgement and experience are required to check and interpret the measurements collected and transmitted.
This device is not for use in systems which substitute for medical care.
This device is not intended for patients requiring direct medical supervision or emergency intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041816: RTX3320PSTN Wireless Telehealth Gateway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041816
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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