510(k) · Cleared
ClearedMEDIC4ALL Telemedicine System, Model VMS-01 (Nibp)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medic4all (Israel), Ltd. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 8, 2006 as substantially equivalent to K023749 (Philips Medical Systems, 2002) and 1 other predicate after a 106-day review. Its family tree reaches back 8 generations to 1987. 2 later devices descend from it.
- Decided
- Nov 8, 2006
- Review
- 106 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). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK062127 MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp)Medic4all (Israel), Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK080091 Modification to:Health Buddy ApplianceHealth Hero Network, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK091021 Modification to Medicompass ConnectImetrikus, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView 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) | K062127 | MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp) | Medic4all (Israel), Ltd. | 2006 | — |
| +1 | K080091 | Modification to:Health Buddy Appliance | Health Hero Network, Inc. | 2008 | — |
| +2 | K091021 | Modification to Medicompass Connect | Imetrikus, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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.
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 |
|---|---|---|---|
| * | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Summary page 1…S-01 Predicate Devices: The VMS-01 is substantially equivalent to: * The Philips Medical Systems M3810A TeleMonitoring System with M3812B TefeStation (K023749). * The BL-Healthcare, Inc. Remote Care Management System (K051470). 8… | 2002 |
| * | K051470 | Remote Care Management Systems (RCMS)Summary page 1…* The Philips Medical Systems M3810A TeleMonitoring System with M3812B TefeStation (K023749). * The BL-Healthcare, Inc. Remote Care Management System (K051470). 8… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080091 | Modification to:Health Buddy Appliance | 2008 | 1 |
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 19 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K080091 (Health Hero Network, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K023749.
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.
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 Medic4AII Telemedicine System Model VMS-01 is intended to collect and transmit
physiological information, such as noninvasive blood pressure, via standard telephone
lines or the internet to local or remote computer systems for use by the patient or a
healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062127: MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062127
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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