510(k) · Cleared
ClearedCarecompanion Patient Station & Nurse Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neptec Design Group, Ltd. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 29, 2003 as substantially equivalent to K020584 (Neptec Design Group, Ltd., 2002) and 5 other predicates after a 318-day review. Its family tree reaches back 4 generations to 1991. 39 later devices descend from it.
- Decided
- May 29, 2003
- Review
- 318 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K910772 (1991). 18 ancestors in all, the oldest K893221 (1990). 39 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 3 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- This deviceK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- Descendant · cites it directly · 34 of its ownK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- Descendant · 2 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 3 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K041308Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004 · cites it directly34descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 2 generations on25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 3 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 3 generations on12descendants
- K101178Modification to Intel Health Guide PHS6000Intel Corp. · 2010 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −3 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| +1 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| +2 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +3 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +3 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| +3 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (6)
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 |
|---|---|---|---|
| * | K020584 | N2000 Base Station; N2001 Nurse StationSummary page 2…unctions. Substantial Equivalence The Neptec Carecompanion with the addition of the pulse oximeter is substantially equivalent to the predicate Neptec CareCompanion (#K020584) that has previously been approved by the FDA. The Carecompanion and its predicate have the same general use to provide the capa… | 2002 |
| * | K002690 | Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Summary page 2…on of blood oxygen saturation data. The pulse oximeter is substantially equivalent to the following FDA approved devices: 0 Nonin Palmsat Pulse Oximeter Model 2500 (#K002690) by Nonin Medical, Inc. 0 9303 NeonataVAdult Vital Signs Monitor (#K982776) by CAS Medical Systems, Inc. 0 Escort I1 Modular… | 2000 |
| * | K982776 | 9303 Neonatal/Adult Vital Signs MonitorSummary page 2…valent to the following FDA approved devices: 0 Nonin Palmsat Pulse Oximeter Model 2500 (#K002690) by Nonin Medical, Inc. 0 9303 NeonataVAdult Vital Signs Monitor (#K982776) by CAS Medical Systems, Inc. 0 Escort I1 Modular Telemetry System (#K970763) by Medical Data Electronics, Inc. DR180-WOxy… | 1998 |
| * | K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II MonitorSummary page 2…Model 2500 (#K002690) by Nonin Medical, Inc. 0 9303 NeonataVAdult Vital Signs Monitor (#K982776) by CAS Medical Systems, Inc. 0 Escort I1 Modular Telemetry System (#K970763) by Medical Data Electronics, Inc. DR180-WOxy Holter and Pulse Oximetry Recorder (#K983576) by Northeast Monitoring, Inc.… | 1997 |
| * | K983576 | DR180-R/OxySummary page 2…776) by CAS Medical Systems, Inc. 0 Escort I1 Modular Telemetry System (#K970763) by Medical Data Electronics, Inc. DR180-WOxy Holter and Pulse Oximetry Recorder (#K983576) by Northeast Monitoring, Inc. Digital EEG and Sleep Acquisition System (#K990522) by La Mont Medical, Inc. Intended U… | 1999 |
| * | K990522 | Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse…Summary page 2…ical Data Electronics, Inc. DR180-WOxy Holter and Pulse Oximetry Recorder (#K983576) by Northeast Monitoring, Inc. Digital EEG and Sleep Acquisition System (#K990522) by La Mont Medical, Inc. Intended Use The Patient Station is intended to be used upon prescription of an authorized healthca… | 1999 |
What descends from it? (39)
See all 392 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K041308 (Webvmc, LLC, 2004) has gone furthest, with 34 descendants of its own.
- 2 other devices also cite its predicate K020584.
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 Carecompanion Patient Station is intended to be used in conjunction with the Carecompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional. The Carecompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular moitoring of vital signs information is indicated. The information is collected from the Carecompanion Patient…
Read the full statement (125 words)
The Carecompanion Patient Station is intended to be used in conjunction with the Carecompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The Carecompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular moitoring of vital signs information is indicated. The information is collected from the Carecompanion Patient Station and transmitted over standard telephone lines to a health care professional.
The device does not send any real-time alarms. The device a aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022274: Carecompanion Patient Station & Nurse Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022274
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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