510(k) · Cleared
ClearedHolter ECG and ABP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Sep 25, 2023 as substantially equivalent to K111096 (Vasomedical, Inc., 2011) after a 245-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Sep 25, 2023
- Review
- 245 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943862 (1995). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- 5 generations backK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- 4 generations backK070818 MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH · 2007
- 3 generations backK083820 Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model…Vasomedical, Inc. · 2009
- 2 generations backK092785 Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder &…Vasomedical, Inc. · 2010
- 1 generation backK111096 Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood…Vasomedical, Inc. · 2011
- This deviceK230184 Holter ECG and ABP SystemEdan Instruments, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| −5 | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| −4 | K070818 | MEDILOGAR4, MEDILOGAR12 | Tom Medical Entwicklungs GmbH | 2007 | — |
| −3 | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C | Vasomedical, Inc. | 2009 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K111096 | Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Summary page 5…dicate Device(s): 1) Vasomedical, Inc., Combined 12 Channel Ambulatory EGG and Blood Pressure Recorder, Model 2302, cleared under K111096 (Primary). 2) Vasomedical, Inc., Combined Ambulatory EGG and Blood Pressure… | 2011 |
| † | K092785 | Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software… | 2010 |
| † | K151787 | Holter System | 2016 |
| † | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | 2021 |
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 11 ancestors has a recall.
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?
The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor.
It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder.
It is intended to be used by trained personnel under the direction of doctors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230184: Holter ECG and ABP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230184
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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