510(k) · Cleared
ClearedCarematix Wellness System, Model CWS-5000.1-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carematix, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 5, 2010 as substantially equivalent to K040966 (Carematix, Inc., 2004) and 1 other predicate after a 72-day review. Its family tree reaches back 8 generations to 1987. 2 later devices descend from it.
- Decided
- May 5, 2010
- Review
- 72 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K864318 (1987). 19 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 backK073038 Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc. · 2008
- This deviceK100508 Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK122333 Mobilecare MonitorAframe Digital, Inc. · 2012
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 | K073038 | Carematix Wellness System, Model CWS-5000.1-B | Carematix, Inc. | 2008 | — |
| 0 (this device) | K100508 | Carematix Wellness System, Model CWS-5000.1-B | Carematix, Inc. | 2010 | — |
| +1 | K103796 | Telemedcare Health Monitor | Telemedcare Pty, Ltd. | 2011 | — |
| +2 | K122333 | Mobilecare Monitor | Aframe Digital, Inc. | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K040966 | Modification to Carematix Wellness SystemSummary page 1…DRG Classification Panel: Cardiovascular Device Panel Regulation Number: 21 CFR 870.291 0 PREDICATE DEVICES K040966; K073038- CarematixTh Weilness System, Carematix, In1c. DESCRIPTION OF DEVICE The Carematix~m Wellness System is… | 2004 |
| * | K073038 | Carematix Wellness System, Model CWS-5000.1-BSummary page 1…Classification Panel: Cardiovascular Device Panel Regulation Number: 21 CFR 870.291 0 PREDICATE DEVICES K040966; K073038- CarematixTh Weilness System, Carematix, In1c. DESCRIPTION OF DEVICE The Carematix~m Wellness System is intended… | 2008 |
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 |
|---|---|---|---|
| K103796 | Telemedcare Health Monitor | 2011 | 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 23 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K103796 (Telemedcare Pty, Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 15 other devices also cite its predicate K040966.
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 CarematiXTM Wellness System is a physiological monitdring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the heaaithcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: Non-invasive blood pressure measurement; Pulse rate measurement; Blood glucose level using a…
Read the full statement (141 words)
The CarematiXTM Wellness System is a physiological monitdring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the heaaithcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:
Non-invasive blood pressure measurement;
Pulse rate measurement;
Blood glucose level using a Glucometer;
Blood hemoglobin oxygen saturation (%SPO 2) using a digital Pulse Oximeter;
Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system;
Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;
Patient weight using a stand-on electronic scale
The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100508 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100508: Carematix Wellness System, Model CWS-5000.1-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100508
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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