510(k) · Cleared
ClearedRTX 3371
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tunstall Healthcare · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Apr 15, 2009 as substantially equivalent to K071953 (Rtx Healthcare A/S, 2007) and 1 other predicate after a 15-day review. Its family tree reaches back 10 generations to 1987. 2 later devices descend from it.
- Decided
- Apr 15, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K864318 (1987). 32 ancestors in all, the oldest K790130 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations between
- 3 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 2 generations backK062304 DLM112 Daylink MonitorRtx Healthcare A/S · 2006
- 1 generation backK071953 RTX3370Rtx Healthcare A/S · 2007
- This deviceK090886 RTX 3371Tunstall Healthcare · 2009
- Descendant · cites it directly · 1 of its ownK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK122333 Mobilecare MonitorAframe Digital, Inc. · 2012
Show all 10 generations
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 8 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 7 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 6 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 5 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 4 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 3 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 2 generations backK062304 DLM112 Daylink MonitorRtx Healthcare A/S · 2006
- 1 generation backK071953 RTX3370Rtx Healthcare A/S · 2007
- This deviceK090886 RTX 3371Tunstall Healthcare · 2009
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 |
|---|---|---|---|---|---|
| −10 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −9 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −8 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −7 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −6 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −5 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −4 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −3 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −2 | K062304 | DLM112 Daylink Monitor | Rtx Healthcare A/S | 2006 | — |
| −1 | K071953 | RTX3370 | Rtx Healthcare A/S | 2007 | — |
| 0 (this device) | K090886 | RTX 3371 | Tunstall Healthcare | 2009 | — |
| +1 | K103796 | Telemedcare Health Monitor | Telemedcare Pty, Ltd. | 2011 | — |
| +2 | K122333 | Mobilecare Monitor | Aframe Digital, Inc. | 2012 | — |
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 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K071953 | RTX3370Summary page 1…nsmitter and Receiver. Product code: DRG Predicate Devices: The RTX3371 device is substantially equivalent to the following predicate devices: 510(k) number: K071953 Device name: RTX3370 Applicant: Tunstall Healthcare 510(k) number: K072698 Device name: Confidant… | 2007 |
| * | K072698 | Confidant 2.5Summary page 1…tially equivalent to the following predicate devices: 510(k) number: K071953 Device name: RTX3370 Applicant: Tunstall Healthcare 510(k) number: K072698 Device name: Confidant 2.5 Applicant: Confidant International, [[C Submission Device Description: The RTX337… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103796 | Telemedcare Health Monitor | 2011 | 1 |
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 22 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 32 ancestors have a recall of any class.
- Of its descendants, K103796 (Telemedcare Pty, Ltd., 2011) has gone furthest, with 1 descendant 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. 2009, 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 RTX3371 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3371 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare…
Read the full statement (127 words)
The RTX3371 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3371 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) using standard wireless technologies.
The RTX3371 does not measure, interpret or make any decisions on the vital data that it conveys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090886: RTX 3371.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090886
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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