510(k) · Cleared
ClearedCsi Managed Health System Model: Csi Model 9K
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 Aug 4, 2010 as substantially equivalent to K093389 (Computerized Screening, Inc., 2009) and 2 other predicates after a 97-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it.
- Decided
- Aug 4, 2010
- Review
- 97 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K910772 (1991). 38 ancestors in all, the oldest K850893 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- 3 generations backK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- 2 generations backK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- 1 generation backK063008 Health Check KioskXperex Corporation · 2007
- This deviceK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK153600 Consult Station TSH4D Sas · 2017
Most influential descendants
Showing 1 of 1 · See all- K153600Consult Station TSH4D Sas · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −7 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| −3 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| −2 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| −1 | K063008 | Health Check Kiosk | Xperex Corporation | 2007 | — |
| 0 (this device) | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
| +1 | 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 |
| 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 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K093389 | Csi Model 5K Managed Health System KioskSummary page 1…Product Code: DX-N Subsequent Product Codes: ELL Classification: Class II III. Predicate Devices K093389: CSL Model 5K K090294: ForaCare 1R22 Digital Thermometer K063 008: Health Check Kiosk… | 2009 |
| * | K090294 | Fora IR22 Ear Thermometer, Model TD-1262Summary page 1…Subsequent Product Codes: ELL Classification: Class II III. Predicate Devices K093389: CSL Model 5K K090294: ForaCare 1R22 Digital Thermometer K063 008: Health Check Kiosk The blood pressure, weight and puls… | 2009 |
| * | K063008 | Health Check KioskSummary page 1…sification: Class II III. Predicate Devices K093389: CSL Model 5K K090294: ForaCare 1R22 Digital Thermometer K063 008: Health Check Kiosk The blood pressure, weight and pulse measurement systems used in Model 9K is exactly t… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153600 | Consult Station TS | 2017 | 0 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K153600 (H4D Sas, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093389.
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. 2010, 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?
CSI Model 9K Managed Health System Kiosk is an automated non invasive screening
device intended for voluntary use by the general public.. The device measures systolic
and diastolic blood pressure, pulse and if optionally equipped, weight and temperature.
Users may also manually enter or download blood glucose level. Data from the Model
9K may be stored by the user for tracking purposes. It is not a diagnostic device, and
only fuirnishes data so users can consult their personal physicians.
The device is intended for users fourteen years or older. Children under the age of
fourteen must be accompanied by an adult.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101198: Csi Managed Health System Model: Csi Model 9K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101198
Report an extraction error
Are you the manufacturer?
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