510(k) · Cleared
ClearedFora GW 9014 Telehealth Gateway/TD-9014 Telehealth Gateway
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 May 28, 2010 as substantially equivalent to K041816 (Rtx Healthcare A/S, 2004) after a 101-day review. Its family tree reaches back 6 generations to 1987. 1 later device descends from it.
- Decided
- May 28, 2010
- Review
- 101 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K864318 (1987). 13 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 4 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 3 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 2 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 1 generation backK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
- This deviceK100427 Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth GatewayTaidoc Technology Corporation · 2010
- Descendant · cites it directly · 0 of its ownK103643 Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −5 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −4 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −3 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −2 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −1 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
| 0 (this device) | K100427 | Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth Gateway | Taidoc Technology Corporation | 2010 | — |
| +1 | K103643 | Ascot Home Medical Monitoring System (HMMS) | Ascot Technologies, Inc. | 2011 | — |
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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K041816 | RTX3320PSTN Wireless Telehealth GatewaySummary page 1…20 Wireless TeleHealth Gateway Common/Usual Name: Physiological Transmitter and Receiver Submitter RTX Healthcare A/S 510 (k) Number K041816 K(/oo r-27… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103643 | Ascot Home Medical Monitoring System (HMMS) | 2011 | 0 |
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 23 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K103643 (Ascot Technologies, Inc., 2011) has gone furthest, with 0 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. 2010, 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 GW 9014/TD-9014 TeleHealth Gateway is for use by patients at home or at clinical settings. 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. It serves as the remote communication link between various FDA-cleared compatible monitors and the compatible healthcare facility at another location. The healthcare facility could be with the…
Read the full statement (213 words)
The FORA GW 9014/TD-9014 TeleHealth Gateway is for use by patients at home or at clinical settings. 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. It serves as the remote communication link between various FDA-cleared compatible monitors and the compatible healthcare facility at another location. The healthcare facility could be with the healthcare provider, or at a disease management center, or other out-of-hospital caregivers.
This device is intended to transmit selected medical information (i.e. blood glucose, blood pressure, body weight, body temperature, body fat, and body hydration) measured by FDA approved medical devices via RS232 or wireless connections over the internet or residential telephone line.
This device does not measure, interpret or make any decisions on the data that it conveys.
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. This device is not for use in systems which substitute for medical care, or for patients requiring direct medical supervision.
This device is not intended for patients requiring direct medical supervision or emergency intervention. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100427: Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth Gateway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100427
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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