510(k) · Cleared
ClearedAmbulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 1, 2021 as substantially equivalent to K151520 (Suntech Medical, Inc., 2016) after a 255-day review. Its family tree reaches back 9 generations to 1991. 1 later device descends from it.
- Decided
- Oct 1, 2021
- Review
- 255 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K903134 (1991). 41 ancestors in all, the oldest K855127 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 5 generations between
- 3 generations backK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
- 2 generations backK122129 Sphygmocor XcelAtcor Medical · 2012
- 1 generation backK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- This deviceK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 8 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 7 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 6 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 5 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 4 generations backK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
- 3 generations backK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
- 2 generations backK122129 Sphygmocor XcelAtcor Medical · 2012
- 1 generation backK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- This deviceK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −8 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −7 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −6 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −5 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −4 | K081590 | YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −3 | K083093 | Cheetah Reliant | Cheetah Medical, Inc. | 2008 | 1 |
| −2 | K122129 | Sphygmocor Xcel | Atcor Medical | 2012 | — |
| −1 | K151520 | Oscar 2 | Suntech Medical, Inc. | 2016 | 2 |
| 0 (this device) | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | 2021 | — |
| +1 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K151520 | Oscar 2Summary page 4…sure, Non-Invasive/ Regulatory Class: Class II 3. Predicate Device(s): Suntech Medical, Inc., Oscar 2 NIBP Monitor, cleared under K151520 (Primary) A&D MEDICAL DIV, TM-2430 Ambulatory Blood Pressure M… | 2016 |
| † | K992808 | A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure | 1999 |
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 |
|---|---|---|---|
| K251591 | Holter ECG and ABP system (HolterABP) | 2026 | 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 30 years and passes through 9 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K251591 (Edan Instruments, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151520.
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. 2021, 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 Ambulatory Blood Pressure Monitor is capable of measuring systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are stored in the monitor and can be transferred to analysis system via wire or wireless transmission. It is intended for use as an aid or adjunct to diagnosis and treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210139: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210139
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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