510(k) · Cleared
ClearedABPMpro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomedics GmbH · DSH Recorder, Magnetic Tape, Medical
Cleared on Nov 27, 2023 as substantially equivalent to K092785 (Vasomedical, Inc., 2010) after a 222-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Nov 27, 2023
- Review
- 222 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K943862 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- 4 generations backK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- 3 generations backK070818 MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH · 2007
- 2 generations backK083820 Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model…Vasomedical, Inc. · 2009
- 1 generation backK092785 Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder &…Vasomedical, Inc. · 2010
- This deviceK231104 ABPMproSomnomedics GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| −4 | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| −3 | K070818 | MEDILOGAR4, MEDILOGAR12 | Tom Medical Entwicklungs GmbH | 2007 | — |
| −2 | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C | Vasomedical, Inc. | 2009 | — |
| −1 | K092785 | Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis… | Vasomedical, Inc. | 2010 | — |
| 0 (this device) | K231104 | ABPMpro | Somnomedics GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 18.0 · 22 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 |
|---|---|---|---|
| * | K092785 | Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Summary page 5…tem, Measurement, Blood-Pressure, Non-Invasive Panel: Cardiovascular Product Codes: DSH, DXN Predicate Device: Primary- Vasomedical-Biox, K092785 Reference- SOMNOscreen plus , K201054 Device Description: The ABPMpro is a portable device for… | 2010 |
| † | K201054 | SOMNOscreen plus | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K092785.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro…
Read the full statement (127 words)
ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years.
ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231104: ABPMpro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231104
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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