510(k) · Cleared
ClearedVasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox 3- Channel Miniature Ambulatory
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 Jun 28, 2011 as substantially equivalent to K083820 (Vasomedical, Inc., 2009) after a 62-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jun 28, 2011
- Review
- 62 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943862 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK111180 Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model…Vasomedical, Inc. · 2011
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) | K111180 | Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304… | Vasomedical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 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 |
|---|---|---|---|
| * | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CSummary page 1…3 - Channel Ambulatory ECU Halter Recorder, Model 1305 was granted FDA 510(k) clearance on April 1, 2009 (k083820). 6. Device Description: Vasomedical-Biox 12 - Channel Ambulatory EGG Holter Recorder. and Vasomedical-Bi… | 2009 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K083820.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 12 - Channel Ambulatory EGG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel EGG signals from the upper body surfaces. Cardiac Rhythm is acquired via EGG signals. Vasomedical-Biox 3 - Channel Miniature Ambulatory EGG Bolter Recorder, Model 1303, is also a Non-Invasive device intended to acquire ambulatory 3 - Channel EGG signals from the upper body surfaces. Cardiac rhythm is also acquired…
Read the full statement (144 words)
Vasomedical-Biox 12 - Channel Ambulatory EGG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel EGG signals from the upper body surfaces. Cardiac Rhythm is acquired via EGG signals.
Vasomedical-Biox 3 - Channel Miniature Ambulatory EGG Bolter Recorder, Model 1303, is also a Non-Invasive device intended to acquire ambulatory 3 - Channel EGG signals from the upper body surfaces. Cardiac rhythm is also acquired via EGG signals.
The Bolter Recorders are intended for adults and children who are over the age of six years.
The Models 1304 and 1303 work with the GB Series EGG Analysis Software which has been previously cleared under (k083820)
"The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications"..
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/K111180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111180: Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox 3- Channel Miniature Ambulatory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111180
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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