510(k) · Cleared
ClearedHealth Check Kiosk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xperex Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 7, 2007 as substantially equivalent to K040562 (Lifeclinic International, Inc., 2004) and 2 other predicates after a 248-day review. Its family tree reaches back 7 generations to 1991. 4 later devices descend from it.
- Decided
- Jun 7, 2007
- Review
- 248 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K910772 (1991). 34 ancestors in all, the oldest K850893 (1985). 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- 2 generations backK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- 1 generation backK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- This deviceK063008 Health Check KioskXperex Corporation · 2007
- Descendant · cites it directly · 1 of its ownK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK153600 Consult Station TSH4D Sas · 2017
- Descendant · cites it directly · 0 of its ownK143108 HealthGuard-15Futrex, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK113402 Solohealth StationSolohealth, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010 · cites it directly1descendant
- K153600Consult Station TSH4D Sas · 2017 · 2 generations on0descendants
- K143108HealthGuard-15Futrex, Inc. · 2015 · cites it directly0descendants
- K113402Solohealth StationSolohealth, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| −2 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| −1 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| 0 (this device) | K063008 | Health Check Kiosk | Xperex Corporation | 2007 | — |
| +1 | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
| +2 | K153600 | Consult Station TS | H4D Sas | 2017 | — |
| +1 | K143108 | HealthGuard-15 | Futrex, Inc. | 2015 | — |
| +1 | K113402 | Solohealth Station | Solohealth, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 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 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K040562 | Lifeclinic, Model 2400Summary page 1…of Health Parameters Classification name: System, measurement, blood-pressure, non-invasive (3) Equivalent legally-marketed devices. 1. Lifeclinic Inernational, K040562 2. Advanced Monitoring Caregiving, K05 1544 3. Remote Nurse, K0413 08 (4) Description The Health Check Kiosk is a kiosk that is… | 2004 |
| * | K051544 | Vitalcaregiving SystemSummary page 1…name: System, measurement, blood-pressure, non-invasive (3) Equivalent legally-marketed devices. 1. Lifeclinic Inernational, K040562 2. Advanced Monitoring Caregiving, K05 1544 3. Remote Nurse, K0413 08 (4) Description The Health Check Kiosk is a kiosk that is erected in public spaces, and provides a lo… | 2005 |
| * | K041308 | Remotenurse Patient Monitoring SystemSummary page 1…blood-pressure, non-invasive (3) Equivalent legally-marketed devices. 1. Lifeclinic Inernational, K040562 2. Advanced Monitoring Caregiving, K05 1544 3. Remote Nurse, K0413 08 (4) Description The Health Check Kiosk is a kiosk that is erected in public spaces, and provides a location where the general -… | 2004 |
What descends from it? (4)
3 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 16 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K101198 (Computerized Screening, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K040562.
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. 2007, 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 Health Check Kiosk is indicated for use by the general public so that a user can measure his/her own health parameters using devices cleared for use by the public. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063008: Health Check Kiosk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063008
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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