510(k) · Cleared
ClearedCsi Model 5K Managed Health System Kiosk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Screening, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 17, 2009 as substantially equivalent to K063137 (Pharmasmart, Inc., 2007) and 1 other predicate after an 18-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it.
- Decided
- Nov 17, 2009
- Review
- 18 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K910772 (1991). 12 ancestors in all, the oldest K850893 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 4 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK063137 Pharmasmart Public Use Blood Pressure Monitor, Models…Pharmasmart, Inc. · 2007
- This deviceK093389 Csi Model 5K Managed Health System KioskComputerized Screening, Inc. · 2009
- 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 ownK113402 Solohealth StationSolohealth, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −4 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K063137 | Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000 | Pharmasmart, Inc. | 2007 | — |
| 0 (this device) | K093389 | Csi Model 5K Managed Health System Kiosk | Computerized Screening, Inc. | 2009 | — |
| +1 | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
| +2 | K153600 | Consult Station TS | H4D Sas | 2017 | — |
| +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 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K063137 | Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000Summary page 1…system Classification Number: 870.1130 Product Code: DXN Classification: Class II III. Predicate Devices K063137: PharmaSmart, Model PS-1000/PS-1500/PS-2000 K040562: HealthGuard International, Lifeclinic 2400 IV. Intended us… | 2007 |
| * | K040562 | Lifeclinic, Model 2400Summary page 1…Product Code: DXN Classification: Class II III. Predicate Devices K063137: PharmaSmart, Model PS-1000/PS-1500/PS-2000 K040562: HealthGuard International, Lifeclinic 2400 IV. Intended use of the Device The CSI Model 5K Managed Health Sy… | 2004 |
What descends from it? (3)
2 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 18 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K101198 (Computerized Screening, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K063137.
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. 2009, 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 CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093389: Csi Model 5K Managed Health System Kiosk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093389
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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