510(k) · Cleared
ClearedFora Telehealth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jan 16, 2009 as substantially equivalent to K031840 (Carematix, Inc., 2003) and 1 other predicate after a 94-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Jan 16, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K864318 (1987). 20 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 6 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 5 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 4 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 3 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 2 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 1 generation backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- This deviceK083046 Fora Telehealth SystemTaidoc Technology Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −7 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −6 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −5 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −4 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −3 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −2 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −1 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| 0 (this device) | K083046 | Fora Telehealth System | Taidoc Technology Corporation | 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 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K031840 | Carematix Wellness SystemSummary page 1…Trade/Propnetary Name Carematix Wellness System Common/Usual Name Telemnedicine system Submitter Carematix, Inc 510 (k) Number K031 840 Trade/Propnetary Name BL Healthcare Remote Care Management system Common/Usual Name Telemnedicine system Submitter… | 2003 |
| * | K051470 | Remote Care Management Systems (RCMS)Summary page 1…BL Healthcare Remote Care Management system Common/Usual Name Telemnedicine system Submitter BL Healtheare, Inc 510 (k)Number K051470 1/3… | 2005 |
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 22 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 20 ancestors have a recall of any class.
- 3 other devices also cite its predicate K031840.
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 FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The system serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center The system is intended to…
Read the full statement (170 words)
The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The system serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of'the historical test results, home users and healthcare professionals can do health management effectively
The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropnate healthcare professional
This system is to be used or prescnbed on the order of a physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083046: Fora Telehealth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083046
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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