510(k) · Cleared
ClearedPharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmasmart, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 1, 2007 as substantially equivalent to K040562 (Lifeclinic International, Inc., 2004) and 1 other predicate after a 197-day review. Its family tree reaches back 4 generations to 1991. 5 later devices descend from it.
- Decided
- May 1, 2007
- Review
- 197 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K910772 (1991). 11 ancestors in all, the oldest K850893 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 3 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- This deviceK063137 Pharmasmart Public Use Blood Pressure Monitor, Models…Pharmasmart, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK093389 Csi Model 5K Managed Health System KioskComputerized Screening, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK153600 Consult Station TSH4D Sas · 2017
- Descendant · cites it directly · 0 of its ownK140360 Health KioskEngagementhealth, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK113402 Solohealth StationSolohealth, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K093389Csi Model 5K Managed Health System KioskComputerized Screening, Inc. · 2009 · cites it directly3descendants
- K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010 · 2 generations on1descendant
- K153600Consult Station TSH4D Sas · 2017 · 3 generations on0descendants
- K140360Health KioskEngagementhealth, LLC · 2015 · cites it directly0descendants
- K113402Solohealth StationSolohealth, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −3 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K063137 | Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000 | Pharmasmart, Inc. | 2007 | — |
| +1 | K093389 | Csi Model 5K Managed Health System Kiosk | Computerized Screening, Inc. | 2009 | — |
| +2 | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
| +3 | K153600 | Consult Station TS | H4D Sas | 2017 | — |
| +1 | K140360 | Health Kiosk | Engagementhealth, LLC | 2015 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K040562 | Lifeclinic, Model 2400Summary page 1…ernational and the 9303 Neonatal/Adult Vital Signs Monitor from CAS Medical Systems. The LC500 was cleared by the FDA on August 31, 2004 under 510(k) K0405 62. The 93 03 was cleared by the FDA on November 2, 1998 under 5 10(k) K982776. IV. Intended Use of the Device… | 2004 |
| * | K982776 | 9303 Neonatal/Adult Vital Signs MonitorSummary page 1…ystems. The LC500 was cleared by the FDA on August 31, 2004 under 510(k) K0405 62. The 93 03 was cleared by the FDA on November 2, 1998 under 5 10(k) K982776. IV. Intended Use of the Device The PharmaSmart Models PS-10OO, PS-1500 and PS-2000 are indicated for… | 1998 |
What descends from it? (5)
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 16 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K093389 (Computerized Screening, Inc., 2009) has gone furthest, with 3 descendants 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 PharmaSmart Models PS-1000, PS-1500 and PS-2000 are indicated for use for non-invasive oscillometric blood pressure and pulse rate monitoring by the general public in a sit down kiosk form. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063137: Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063137
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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