510(k) · Cleared
ClearedAlly Platform System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Continuity Health Solutions · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 20, 2010 as substantially equivalent to K090801 (Express MD Solutions, LLC, 2009) and 1 other predicate after a 153-day review. Its family tree reaches back 11 generations to 1987. 1 of the 74 devices in its family, counting itself, has a Class I recall.
- Decided
- May 20, 2010
- Review
- 153 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K864318 (1987). 73 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet. 1 of the 74 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations between
- 3 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 2 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- This deviceK093895 Ally Platform SystemContinuity Health Solutions · 2010
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 backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 3 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 2 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- This deviceK093895 Ally Platform SystemContinuity Health Solutions · 2010
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes4 generations back · 2002
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 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −3 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −2 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −1 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| 0 (this device) | K093895 | Ally Platform System | Continuity Health Solutions | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 10 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 1 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K090801 | Electronic House CallSummary page 1…CFR section: 870.2910 Physiological Signal Transmitters and Receivers Product code: DRG Panel: Cardiology VI. PREDICATE DEVICES: K090801I Electronic House Call System Class II Decision Date: 04/08/2009 K063612 Health he… | 2009 |
| * | K063612 | Modification to Health Buddy ApplianceSummary page 1…Panel: Cardiology VI. PREDICATE DEVICES: K090801I Electronic House Call System Class II Decision Date: 04/08/2009 K063612 Health hero Network Class 11 Decision Date: 12/29/2006 VII. SUBSTANTIAL EQUIVALENCE… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 11 of the 73 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K090801.
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 ALLYT Platform System is a multi-platform medical device that is an accessory to approved 510k devices and is intended to be used as a means of receiving, storing, and transmitting patient biomnetric. data including vital signs measurements. The ALLYm Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider. The ALLYT Platform System will send information to a remote database to be accessed by…
Read the full statement (176 words)
The ALLYT Platform System is a multi-platform medical device that is an accessory to approved 510k devices and is intended to be used as a means of receiving, storing, and transmitting patient biomnetric. data including vital signs measurements. The ALLYm Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider.
The ALLYT Platform System will send information to a remote database to be accessed by authorized clients, such as healthcare professionals or patient family members. Electronic data consisting of patient vital sign information, educational material, reminders, questionnaires, and patient responses are exchanged over a secure network connection. Information may be communicated via standard telephone lines, high speed intermet connections, serial port interfaces, or BluetoothO radio transceivers.
The ALLYT Platform is a multi-platform application that is not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts. The ALLYm Platform is not intended to act as an emergency response system. All patient medical diagnosis and treatment are to be performed by an appropriate health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093895: Ally Platform System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093895
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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