510(k) · Cleared
ClearedVitalograph Model 7100 - Vitalojak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalograph (Ireland), Ltd. · DSH Recorder, Magnetic Tape, Medical
Cleared on Nov 23, 2011 as substantially equivalent to K101022 (Karmelsonix, 2010) after a 273-day review. Its family tree reaches back 5 generations to 1995. 5 later devices descend from it.
- Decided
- Nov 23, 2011
- Review
- 273 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K943862 (1995). 11 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- 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 backK101022 Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
- This deviceK110525 Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK201077 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020
- Descendant · 2 generations on · 2 of its ownK220893 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK223382 AeviceMDAevice Health Pte., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253293 VitaloJAK Clinic (Model 7100)Vitalograph, Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK243603 AeviceMDAevice Health Pte., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020 · cites it directly3descendants
- K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022 · 2 generations on2descendants
- K223382AeviceMDAevice Health Pte., Ltd. · 2023 · 3 generations on1descendant
- K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd. · 2025 · cites it directly0descendants
- K243603AeviceMDAevice Health Pte., Ltd. · 2025 · 4 generations on0descendants
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 | K101022 | Pulmotrack 5050 Wholter, Model 5050 | Karmelsonix | 2010 | — |
| 0 (this device) | K110525 | Vitalograph Model 7100 - Vitalojak | Vitalograph (Ireland), Ltd. | 2011 | — |
| +1 | K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | 2020 | — |
| +2 | K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | 2022 | — |
| +3 | K223382 | AeviceMD | Aevice Health Pte., Ltd. | 2023 | — |
| +1 | K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph, Ltd. | 2025 | — |
| +4 | K243603 | AeviceMD | Aevice Health Pte., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K101022 | Pulmotrack 5050 Wholter, Model 5050Summary page 1…facturer :Karmelsonix Device Name :Pulmotrack 5050 Who Iter {(Recorder, magnetic tape, medical} 5 10(k) No :K101022 8. Intended Use / Description of Device: The Model 7100 is a non-invasive battery operated device intended to acquire, record… | 2010 |
What descends from it? (5)
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 16 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K201077 (Strados Labs, 2020) has gone furthest, with 3 descendants of its own.
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?
The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis on a windows based PC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110525: Vitalograph Model 7100 - Vitalojak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110525
Report an extraction error
Are you the manufacturer?
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