510(k) · Cleared
ClearedConsult Station TS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H4D Sas · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 17, 2017 as substantially equivalent to K101198 (Computerized Screening, Inc., 2010) and 2 other predicates after a 457-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Mar 17, 2017
- Review
- 457 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910772 (1991). 48 ancestors in all, the oldest K850893 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations between
- 3 generations backK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- 2 generations backK063008 Health Check KioskXperex Corporation · 2007
- 1 generation backK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
- This deviceK153600 Consult Station TSH4D Sas · 2017
Show all 9 generations
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 8 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- 4 generations backK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- 3 generations backK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- 2 generations backK063008 Health Check KioskXperex Corporation · 2007
- 1 generation backK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
- This deviceK153600 Consult Station TSH4D Sas · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −8 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| −4 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| −3 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| −2 | K063008 | Health Check Kiosk | Xperex Corporation | 2007 | — |
| −1 | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
| 0 (this device) | K153600 | Consult Station TS | H4D Sas | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K101198 | Csi Managed Health System Model: Csi Model 9KSummary page 5…dicate device: • CSI Model 9K Managed Health System, manufactured by Computerized Screening, Inc. and cleared for commercial distribution under 510(k) K101198; Among the FDA Class II device components of the Consult Station, the non-invasive blood pressure module and the thermometer carr… | 2010 |
| * | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705CSummary page 5…the EU; however, they are not cleared in the US. Nevertheless, this blood pressure module is substantially equivalent to Omron Hem-705CP Automated Monitor System (510(k) K903134) and the temperature module is equivalent to Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10… | 1991 |
| * | K160816 | Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) Cleared while this submission was under review Summary page 5…or System (510(k) K903134) and the temperature module is equivalent to Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) (510k number K160816). • Omron Hem-705CP Automated Monitor System 510(k) K903134; • Infrared Thermometer (Model: LX-26E, LX-260TE, PRO… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 48 ancestors have a recall of any class.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Consult Station TS is intended to be used by the general public to perform a health check, including the measurement of certain vital signs (weight, BMI, temperature, blood pressure and pulse rate). The lay user autonomously self-performs all the measurements listed above. Using an audio-video conferencing feature incorporated in the Consult Station TS to connect with a healthcare professional remotely, it is possible to perform additional…
Read the full statement (175 words)
The Consult Station TS is intended to be used by the general public to perform a health check, including the measurement
of certain vital signs (weight, BMI, temperature, blood pressure and pulse rate). The lay user autonomously self-performs
all the measurements listed above.
Using an audio-video conferencing feature incorporated in the Consult Station TS to connect with a healthcare
professional remotely, it is possible to perform additional examinations: ENT (Ear, Nose, Throat) and skin examinations,
auscultations sounds and blood oxygen level. The lay user and the healthcare professional are able to see and to interact
each other.
The Consult Station TS is not intended for diagnostic use. Lay users should consult their personal physician if they have
concerns regarding the results of their health check.
The Consult Station TS is intended for lay users of fourteen (14) years old or older. The Consult Station TS is not
intended for children under the age of fourteen.
The Consult Station can be deployed in indoor public areas, such as: pharmacies, senior living communities, shopping
centers, corporations, etc.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153600: Consult Station TS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153600
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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