510(k) · Cleared
ClearedCombined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasomedical, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Apr 2, 2010 as substantially equivalent to K003004 (Suntech Medical Instruments, Inc., 2000) and 1 other predicate after a 204-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 2, 2010
- Review
- 204 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K943862 (1995). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- 3 generations backK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- 2 generations backK070818 MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH · 2007
- 1 generation backK083820 Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model…Vasomedical, Inc. · 2009
- This deviceK092785 Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder &…Vasomedical, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK111096 Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood…Vasomedical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK231104 ABPMproSomnomedics GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK230184 Holter ECG and ABP SystemEdan Instruments, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Vasomedical, Inc. · 2011 · cites it directly1descendant
- K231104ABPMproSomnomedics GmbH · 2023 · cites it directly0descendants
- K230184Holter ECG and ABP SystemEdan Instruments, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| −3 | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| −2 | K070818 | MEDILOGAR4, MEDILOGAR12 | Tom Medical Entwicklungs GmbH | 2007 | — |
| −1 | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C | Vasomedical, Inc. | 2009 | — |
| 0 (this device) | K092785 | Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis… | Vasomedical, Inc. | 2010 | — |
| +1 | K111096 | Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure… | Vasomedical, Inc. | 2011 | — |
| +1 | K231104 | ABPMpro | Somnomedics GmbH | 2023 | — |
| +2 | K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2023 | 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 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 17.9 · 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? (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 |
|---|---|---|---|
| * | K003004 | Oscar 2, Model 222Summary page 1…r Monitor and GB Series Analysis Software. FDA granted 510(k) clearances for these predicate devices on October 25, 2000 (K003004), and April 1, 2009 (K083820). 6. Device Description: Vasomedical's Ambulatory EGG and Blood Pressure Recorder is… | 2000 |
| * | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CSummary page 1…sis Software. FDA granted 510(k) clearances for these predicate devices on October 25, 2000 (K003004), and April 1, 2009 (K083820). 6. Device Description: Vasomedical's Ambulatory EGG and Blood Pressure Recorder is intended to be used… | 2009 |
What descends from it? (3)
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 15 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K111096 (Vasomedical, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K003004.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Vasomedical-Biox Combined Ambulatory EGG and Blood Pressure Recorder is a Non-Invasive oscillometric device intended to acquire Ambulatory 3 Channel EGG signals and non-invasive Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. The Recorders are intended for adults and children Who are over the age of six years. Vasomedical-Biox Ambulatory EGG CB Series Analysis System Software allows transfer of…
Read the full statement (126 words)
Vasomedical-Biox Combined Ambulatory EGG and Blood Pressure Recorder is a Non-Invasive oscillometric device intended to acquire Ambulatory 3 Channel EGG signals and non-invasive Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. The Recorders are intended for adults and children Who are over the age of six years.
Vasomedical-Biox Ambulatory EGG CB Series Analysis System Software allows transfer of EGG and Blood Pressure data from the Recorder to a Windows based PC-based computer program via a removable and large capacity storage card (SD) for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostic 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/K092785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092785: Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092785
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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