510(k) · Cleared
ClearedAmbulo 2400 Ambulatory Blood Pressure Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 25, 2014 as substantially equivalent to K080274 (Tiba Medical, Inc., 2008) after a 334-day review. Its family tree reaches back 2 generations to 1999. 4 later devices descend from it.
- Decided
- Nov 25, 2014
- Review
- 334 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992808 (1999). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK992808 A&D Medical TM-2430 and TM-2431 Ambulatory Blood PressureA&D Medical Div. · 1999
- 1 generation backK080274 Ambulo 2400Tiba Medical, Inc. · 2008
- This deviceK133989 Ambulo 2400 Ambulatory Blood Pressure Monitoring SystemMortara Instrument, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK251581 Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K151520Oscar 2Suntech Medical, Inc. · 2016 · cites it directly3descendants
- K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc. · 2021 · 2 generations on1descendant
- K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026 · 2 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992808 | A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure | A&D Medical Div. | 1999 | — |
| −1 | K080274 | Ambulo 2400 | Tiba Medical, Inc. | 2008 | — |
| 0 (this device) | K133989 | Ambulo 2400 Ambulatory Blood Pressure Monitoring System | Mortara Instrument, Inc. | 2014 | — |
| +1 | K151520 | Oscar 2 | Suntech Medical, Inc. | 2016 | 2 |
| +2 | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | 2021 | — |
| +2 | K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026 | — |
| +3 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K080274 | Ambulo 2400Summary page 4…which S.E. is claimed: Mortara Ambulo 2400 Predicate 510(k) Number Predicate Manufacturer / Model System, Measurement, Blood- K080274 Tiba Medical / Ambulo 2400 Pressure, Non-Invasive Description: The Ambulo 2400 is a compact, lig… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151520 | Oscar 2 | 2016 | 3 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151520 (Suntech Medical, Inc., 2016) has gone furthest, with 3 descendants of its own.
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. 2014, 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 Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates.
The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults and pediatric patients, using the oscillometric method on a cuffed arm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133989 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133989: Ambulo 2400 Ambulatory Blood Pressure Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133989
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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