510(k) · Cleared
ClearedWaldo Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldo Health · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Apr 12, 2011 as substantially equivalent to K080798 (Intel Corp., 2008) and 1 other predicate after a 67-day review. Its family tree reaches back 13 generations to 1987. 1 later device descends from it.
- Decided
- Apr 12, 2011
- Review
- 67 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K864318 (1987). 61 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations between
- 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 1 generation backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- This deviceK110334 Waldo Patient MonitorWaldo Health · 2011
- Descendant · cites it directly · 0 of its ownK111922 Vocare Myhealth TabletVocare, Inc. · 2011
Show all 13 generations
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 6 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 5 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 4 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 1 generation backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- This deviceK110334 Waldo Patient MonitorWaldo Health · 2011
Most influential descendants
Showing 1 of 1 · See all- K111922Vocare Myhealth TabletVocare, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −12 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −11 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −10 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −9 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −8 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −7 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −6 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −5 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −4 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −3 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −2 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −1 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| 0 (this device) | K110334 | Waldo Patient Monitor | Waldo Health | 2011 | — |
| +1 | K111922 | Vocare Myhealth Tablet | Vocare, Inc. | 2011 | — |
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 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 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? (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 |
|---|---|---|---|
| * | K080798 | Intel Health Guide, Model: PHS6000Summary page 1…or IDENTIFICATION OF PREDICATE DEVICE(S) Predicate devices include: - Intel Health Guide PHS6000 (K080798) - MedApps 2.0 (K083862) Wa… | 2008 |
| * | K083862 | Medapps 2.0 Remote Patient Monitoring SystemSummary page 1…s include: - Intel Health Guide PHS6000 (K080798) - MedApps 2.0 (K083862) Waldo Health Waldo Health 4505 Spicewood Spdngs Road, Suite 333… | 2009 |
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 |
|---|---|---|---|
| K111922 | Vocare Myhealth Tablet | 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 24 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 61 ancestors have a recall of any class.
- Of its descendants, K111922 (Vocare, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K080798.
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?
The Waldo Patient Monitor is a remote patient monitor device available by prescription. The Waldo Patient Monitor is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The Waldo Patient Monitor provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and rear-time video conferencing technology.…
Read the full statement (262 words)
The Waldo Patient Monitor is a remote patient monitor device available by prescription. The Waldo Patient Monitor is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The Waldo Patient Monitor provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and rear-time video conferencing technology.
The Waldo Patient Monitor connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The Waldo Patient Monitor stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless Internet or Ethernet.
Healthcare professionals can review the transmitted information utilizing the Waldo Health Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded.
The Waldo Health System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.
A list of devices that are compatible with the Waldo Patient Monitor will be available in the user's manual and the Waldo Health website.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110334 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110334: Waldo Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110334
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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