510(k) · Cleared
ClearedYrnsortip Oximanometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cnoga Medical, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 22, 2010 as substantially equivalent to K043217 (A&D Engineering, Inc., 2005) and 2 other predicates after a 210-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Jul 22, 2010
- Review
- 210 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K880572 (1988). 10 ancestors in all, the oldest K822055 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK880572 Ohmeda 2350 Finapres (R) Blood Pressure MonitorOhmeda Medical · 1988
- 2 generations backK014063 Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 2002 · Recalled
- 1 generation backK023338 Portapres Ambulatory Continuous Non Invasive Blood Pressure…Fms, Finapres Medical Systems BV · 2003 · Recalled
- This deviceK093981 Yrnsortip OximanometerCnoga Medical, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK190893 Non-invasive Hemodynamic Blood Pressure MonitorVita-Course Technologies Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190893Non-invasive Hemodynamic Blood Pressure MonitorVita-Course Technologies Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure Monitor | Ohmeda Medical | 1988 | — |
| −2 | K014063 | Task Force Monitor 3040 | Cnsystems Medizintechnik GmbH | 2002 | 1 |
| −1 | K023338 | Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2 | Fms, Finapres Medical Systems BV | 2003 | 1 |
| 0 (this device) | K093981 | Yrnsortip Oximanometer | Cnoga Medical, Ltd. | 2010 | — |
| +1 | K190893 | Non-invasive Hemodynamic Blood Pressure Monitor | Vita-Course Technologies Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K043217 | A&D Medical UA-767PBT Digital Blood Pressure MonitorSummary page 2…he following Predicates: 3.1 A&D Engineering's A&D Medical Ua-767pbt Digital Blood Pressure Monitor (non-invasive), cleared under 5 10(k) number K043217. 3.2 Finapres Medical Systems' Finometer Noninvasive Hemodynamic Monitor, cleared under 5 10(k) number K023723… | 2005 |
| * | K023723 | Finometer Noninvasive Hemodynamic Monitor, Model 1Summary page 2…invasive), cleared under 5 10(k) number K043217. 3.2 Finapres Medical Systems' Finometer Noninvasive Hemodynamic Monitor, cleared under 5 10(k) number K023723. 3.3 Finapress Medical Systems' PortapressAmbulatory Continuous noninvasive bloodpressure monitor, cleared und… | 2003 |
| * | K023338 | Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2Summary page 2…5 10(k) number K023723. 3.3 Finapress Medical Systems' PortapressAmbulatory Continuous noninvasive bloodpressure monitor, cleared under 5 10(k) number K023338. 4. DEVICE DESCRIPTION The Tensori>- Non-invasive Hemodynamic Blood Pressure Monitor measurement… | 2003 |
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 |
|---|---|---|---|
| K190893 | Non-invasive Hemodynamic Blood Pressure Monitor | 2019 | 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 22 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K190893 (Vita-Course Technologies Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K043217.
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?
The TensorTip - Non-invasive Hemodynamic blood pressure monitor trending device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory.
The device is intended for use in the home environment.
It is intended to be used by any person aged above 18 years old
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093981: Yrnsortip Oximanometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093981
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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