510(k) · Cleared
ClearedAscot Home Medical Monitoring System (HMMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascot Technologies, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Oct 6, 2011 as substantially equivalent to K043529 (Roche Diagnostics Corp., 2005) and 3 other predicates after a 297-day review. Its family tree reaches back 11 generations to 1987.
- Decided
- Oct 6, 2011
- Review
- 297 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K864318 (1987). 28 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations between
- 3 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 2 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 1 generation backK083331 Confidant, Model 2.6Confidant, Inc. · 2009
- This deviceK103643 Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc. · 2011
Show all 11 generations
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 9 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 8 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 7 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 6 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 5 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 4 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 3 generations backK062215 Confidant 2.0Confidant, Inc. · 2006
- 2 generations backK072698 Confidant 2.5Confidant, Inc. · 2007
- 1 generation backK083331 Confidant, Model 2.6Confidant, Inc. · 2009
- This deviceK103643 Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −10 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −9 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −8 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −7 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −6 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −5 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −4 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −3 | K062215 | Confidant 2.0 | Confidant, Inc. | 2006 | — |
| −2 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| −1 | K083331 | Confidant, Model 2.6 | Confidant, Inc. | 2009 | — |
| 0 (this device) | 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 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (4)
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 |
|---|---|---|---|
| * | K043529 | Accu-Chek Advisor Insulin Guidance SoftwareSummary page 1…and receiver COMPARISON TO PREDICATE DEVICE We claim substantial equivalence to the currently legally cleared ACCU-CHEK@ Advisor Insulin Guidance Software (K043 529) and OneTouch®& ZoomnTM Diabetes Management Program (K0813 18), Confidant 2.6 (K08333 1), and FORA GW 9014 TeleHealth Gatew… | 2005 |
| * | K081318 | Onetouch Zoom Diabetes Management ProgramSummary page 1…ubstantial equivalence to the currently legally cleared ACCU-CHEK@ Advisor Insulin Guidance Software (K043 529) and OneTouch®& ZoomnTM Diabetes Management Program (K0813 18), Confidant 2.6 (K08333 1), and FORA GW 9014 TeleHealth Gateway Telemedicine System (K 100427).… | 2008 |
| * | K083331 | Confidant, Model 2.6Summary page 1…the currently legally cleared ACCU-CHEK@ Advisor Insulin Guidance Software (K043 529) and OneTouch®& ZoomnTM Diabetes Management Program (K0813 18), Confidant 2.6 (K08333 1), and FORA GW 9014 TeleHealth Gateway Telemedicine System (K 100427).… | 2009 |
| * | K100427 | Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth GatewaySummary page 1…ftware (K043 529) and OneTouch®& ZoomnTM Diabetes Management Program (K0813 18), Confidant 2.6 (K08333 1), and FORA GW 9014 TeleHealth Gateway Telemedicine System (K 100427). b70369… | 2010 |
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 24 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K043529.
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. 2011, 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?
This medical device is indicated for use by patients with known or suspected hypertension or diabetes that a physician wants to monitor blood pressure, pulse, and/or blood glucose at home. This medical device is a software based device which runs on a Windows based Computer or netbook. This medical device receives readings from supported FDA approved devices in the home and serves as a remote communication link between the home and the physician or…
Read the full statement (275 words)
This medical device is indicated for use by patients with known or suspected hypertension or diabetes that a physician wants to monitor blood pressure, pulse, and/or blood glucose at home.
This medical device is a software based device which runs on a Windows based Computer or netbook. This medical device receives readings from supported FDA approved devices in the home and serves as a remote communication link between the home and the physician or qualified medical provider. The physician or qualified medical provider will review the patient information from a web interface and may make medication changes and transmit those changes back to the patient for display on the Home Medical Station(FIMS).
This medical device receives blood pressure, heart rate and blood glucose readings from the supported FDA approved medical devices via USH or serial connection to the HMS. The HMS communicates with the server via standard wireless or wired communication protocols such as cellular data, and wired or wireless internet.
HMMS has been tested to work with Homedics BPA-260-CBL, Omron HEM-790IT and OneTouch Ultra Mini, OneTouch Ultra 2 and OneTouch UltraLink.
This medical device is automation of the exiting process of reporting results to the physician over the phone.
This medical device is not intended to provide real time monitoring. It is not intended for emergency calls or for transmission of any time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
This medical device does not provide diagnosis of any disease or medical condition and is not a substitute for professional healthcare judgment.
This medical device uses standard communication protocols and encryption to protect patient privacy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103643: Ascot Home Medical Monitoring System (HMMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103643
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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