510(k) Report

510(k) · Cleared

Cleared

Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C

K083820510(k) TraditionalCleared Apr 1, 2009100-day reviewClass II21 CFR 870.2800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vasomedical, Inc. · DSH Recorder, Magnetic Tape, Medical

Cleared on Apr 1, 2009 as substantially equivalent to K070818 (Tom Medical Entwicklungs GmbH, 2007) and 1 other predicate after a 100-day review. Its family tree reaches back 3 generations to 1995. 12 later devices descend from it.

Decided
Apr 1, 2009
Review
100 days
Class
Class II
Product code
DSH
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K943862 (1995). 7 ancestors in all. 12 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestor2010: 2 descendants cleared2011: 3 descendants cleared2023: 3 descendants cleared2025: 2 descendants cleared2020: 1 descendant cleared2022: 1 descendant clearedK943862 · Sonicaid Model MR-63 Ambulatory Ecg Recorder · Oxford Instruments Medical Systems · 1995K970902 · Medilog FD4 · Oxford Instruments Medical Systems · 1997K070818 · MEDILOGAR4, MEDILOGAR12 · Tom Medical Entwicklungs GmbH · 20071995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K070818 · MEDILOGAR4, MEDILOGAR12 · Tom Medical Entwicklungs GmbH · 2007K970902 · Medilog FD4 · Oxford Instruments Medical Systems · 1997K943862 · Sonicaid Model MR-63 Ambulatory Ecg Recorder · Oxford Instruments Medical Systems · 19950+5
  1. Root · 3 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
  2. 2 generations backK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
  3. 1 generation backK070818 MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH · 2007
  4. This deviceK083820 Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model…Vasomedical, Inc. · 2009
  5. Descendant · cites it directly · 6 of its ownK101022 Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
  6. Descendant · 2 generations on · 5 of its ownK110525 Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011
  7. Descendant · 3 generations on · 3 of its ownK201077 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020
  8. Descendant · cites it directly · 3 of its ownK092785 Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder &…Vasomedical, Inc. · 2010
  9. Descendant · 4 generations on · 2 of its ownK220893 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010: 22011: 32020: 12022: 12023: 32025: 2
2010high 3 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 12 · See all
  • K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010 · cites it directly6descendants
  • K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011 · 2 generations on5descendants
  • K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020 · 3 generations on3descendants
  • K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc. · 2010 · cites it directly3descendants
  • K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K943862Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems1995—
−2K970902Medilog FD4Oxford Instruments Medical Systems1997—
−1K070818MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH2007—
0 (this device)K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.2009—
+1K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix2010—
+2K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.2011—
+3K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs2020—
+1K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis…Vasomedical, Inc.2010—
+4K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201130
202010
202210
202330
202520
FIG. 1 — Lineage of K083820, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K070818MEDILOGAR4, MEDILOGAR12
Summary page 1
…oducts Division, Medilog Darwin. FDA granted 510(k) clearances for this predicate device on April 6, 2007 under K070818 and December 22, 2005 under K053369. 6. Device Description: Vasomedical's Ambulatory ECG Recorder Model 1305 is…
Tom Medical Entwicklungs GmbH2007—
*K053369Medilog Darwin Holter Analysis
Summary page 1
…granted 510(k) clearances for this predicate device on April 6, 2007 under K070818 and December 22, 2005 under K053369. 6. Device Description: Vasomedical's Ambulatory ECG Recorder Model 1305 is intended to be us…
Huntleigh Healthcare2005—

Also cleared against K070818: 1 other device →

What descends from it? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106
K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc.20103
K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox…Vasomedical, Inc.20110

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 14 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K101022 (Karmelsonix, 2010) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K070818.

How does its category compare?

All DSH devices

DSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DSH

4in 2025

2007: 12008: 12009: 32010: 22011: 62012: 22013: 22014: 12015: 22016: 22017: 32018: 32019: 32020: 42021: 42022: 42023: 62024: 22025: 42026 (partial year): 2
2007high 6 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSH

205in 2025

2009: 84 days median2011: 64 days median2017: 91 days median2018: 269 days median2019: 30 days median2020: 122 days median2021: 263 days median2022: 427 days median2023: 198 days median2025: 205 days median
2007high 427 (2022) · low 30 (2019)2026

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

2009: 12010: 82011: 32012: 12013: 22014: 32015: 82016: 62017: 312018: 302019: 762020: 912021: 1132022: 462023: 652024: 882025: 213
2007high 213 (2025) · low 0 (2007)2025

MAUDE reports naming product code DSH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
200938401
20102—08
201166403
20122—01
20132—02
20141—03
20152—08
20162—06
2017391031
20183269030
2019330076
20204122091
202142630113
20224427046
20236198065
20242—088
202542050213
20262—0—

What is it indicated for?

The Ambulatory ECG Recorder described in this 510(k) Premarket Notification is a non-invasive device intended to acquire, record and store ambulatory three (3) channel ECG signals from the upper body surface of adults and children over the age of six years old for a minimum of 24 hours. It works in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. The software does not perform diagnostics. These data are used by physicians for diagnostic evaluations.

Indications for use as stated in the FDA summary.

Also cleared against K070818

1 other device cites the same predicate.

  • K253562medilogFDSchiller AG · 2026

More from Vasomedical, Inc.

7 FDA decisions under this applicant name. See the company

  • K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox 3- Channel…Vasomedical, Inc. · 2011
  • K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model 2302, Vasomedical-Biox…Vasomedical, Inc. · 2011
  • K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301Vasomedical, Inc. · 2010
  • K033617Eecp Therapy System Model TS4 with/Without Pluse OximetryVasomedical, Inc. · 2004
  • K020857Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External…Vasomedical, Inc. · 2002

Recent decisions in DSH

The DSH category page

  • K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
  • K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026
  • K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd. · 2025
  • K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc. · 2025
  • K243603AeviceMDAevice Health Pte., Ltd. · 2025

https://510kreport.com/device/K083820 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083820

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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