510(k) Report

510(k) · Cleared

Cleared

Health Kiosk

K140360510(k) TraditionalCleared Apr 10, 2015422-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Engagementhealth, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Apr 10, 2015 as substantially equivalent to K063137 (Pharmasmart, Inc., 2007) and 2 other predicates after a 422-day review. Its family tree reaches back 5 generations to 1991.

Decided
Apr 10, 2015
Review
422 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K910772 (1991). 14 ancestors in all, the oldest K850893 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2001: 1 other ancestor2004: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestor1985: 1 other ancestor1992: 1 other ancestorK910772 · Propaq 102, 104 and 106 · Protocol Systems, Inc. · 1991×3: 3 generations cleared close together, K972020 (1998), K980879 (1998), K982776 (1998) K063137 · Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000 · Pharmasmart, Inc. · 20071985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 5 other ancestors5 generations back: 1 other ancestor K063137 · Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000 · Pharmasmart, Inc. · 2007K982776 · 9303 Neonatal/Adult Vital Signs Monitor · Cas Medical Systems, Inc. · 1998K980879 · Oscillomate Nibp / SP02 Ems Monitor · Cas Medical Systems, Inc. · 1998K972020 · Oscillomate Non-Invasive Blood Pressure Monitor · Cas Medical Systems, Inc. · 1998K910772 · Propaq 102, 104 and 106 · Protocol Systems, Inc. · 1991−50
  1. Root · 5 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
  2. 4 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
  3. 3 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
  4. 2 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
  5. 1 generation backK063137 Pharmasmart Public Use Blood Pressure Monitor, Models…Pharmasmart, Inc. · 2007
  6. This deviceK140360 Health KioskEngagementhealth, LLC · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K910772Propaq 102, 104 and 106Protocol Systems, Inc.1991—
−4K972020Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc.1998—
−3K980879Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc.1998—
−2K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc.1998—
−1K063137Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000Pharmasmart, Inc.2007—
0 (this device)K140360Health KioskEngagementhealth, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199010
199210
199310
199510
199710
200110
200410
201310
FIG. 1 — Lineage of K140360, 1991–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K063137Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000
Summary page 5
…K140360 EngagementHealth Kiosk Predicate Devices:  PharmaSmart Inc. – PharmaSmart PS1000/PS1500/PS2000 Public Use Blood Pressure Monitor (K063137)  Stayhealthy Kiosk SH650-C (K123539)  A & D Medical – TM-2655 Digital Blood Pressure Monitor (K010828) Device De…
Pharmasmart, Inc.2007—
*K123539Stayhealthy Health Kiosk, Stayhealthy Healthcenter Kiosk
Summary page 5
…sk Predicate Devices:  PharmaSmart Inc. – PharmaSmart PS1000/PS1500/PS2000 Public Use Blood Pressure Monitor (K063137)  Stayhealthy Kiosk SH650-C (K123539)  A & D Medical – TM-2655 Digital Blood Pressure Monitor (K010828) Device Description: The EngagementHealth Kiosk is a…
Stayhealthy, Inc.2013—
*K010828Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP
Summary page 5
…500/PS2000 Public Use Blood Pressure Monitor (K063137)  Stayhealthy Kiosk SH650-C (K123539)  A & D Medical – TM-2655 Digital Blood Pressure Monitor (K010828) Device Description: The EngagementHealth Kiosk is a device which provides a method for identifying a person’s systolic and di…
A&D Engineering, Inc.2001—

Also cleared against K063137: 1 other device →

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 24 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
  • 1 of the 14 ancestors has a recall of any class.
  • 1 other device also cites its predicate K063137.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DXN

28in 2025

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

What is it indicated for?

The EngagementHealth Kiosk is intended to be used by the general public as a non-invasive multi-functional unit which measures a person’s weight, blood pressure and heart rate. The kiosk is not intended to be a diagnostic device and does not perform any diagnoses. Rather, the kiosk provides the user with weight and systolic/diastolic blood pressure to be used as supplemental data when consulting a professional physician. The EngagementHealth Kiosk is intended to be fully unattended and placed within public or corporate environments. The user can choose to send the data to the EngagementHealth web portal for later data visualization.

Indications for use as stated in the FDA summary.

Also cleared against K063137

1 other device cites the same predicate.

  • K093389Csi Model 5K Managed Health System KioskComputerized Screening, Inc. · 2009

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K140360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140360: Health Kiosk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140360

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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