510(k) · Cleared
ClearedPulmotrack 5050 Wholter, Model 5050
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karmelsonix · DSH Recorder, Magnetic Tape, Medical
Cleared on Jul 9, 2010 as substantially equivalent to K071955 (Karmelsonix, 2007) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 1995. 6 later devices descend from it.
- Decided
- Jul 9, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K943862 (1995). 10 ancestors in all. 6 later devices descend from it, 1 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 deviceK101022 Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
- Descendant · cites it directly · 5 of its ownK110525 Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK201077 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020
- Descendant · 3 generations on · 2 of its ownK220893 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK223382 AeviceMDAevice Health Pte., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK253293 VitaloJAK Clinic (Model 7100)Vitalograph, Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011 · cites it directly5descendants
- K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020 · 2 generations on3descendants
- K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022 · 3 generations on2descendants
- K223382AeviceMDAevice Health Pte., Ltd. · 2023 · 4 generations on1descendant
- K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd. · 2025 · 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) | K101022 | Pulmotrack 5050 Wholter, Model 5050 | Karmelsonix | 2010 | — |
| +1 | K110525 | Vitalograph Model 7100 - Vitalojak | Vitalograph (Ireland), Ltd. | 2011 | — |
| +2 | K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | 2020 | — |
| +3 | K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | 2022 | — |
| +4 | K223382 | AeviceMD | Aevice Health Pte., Ltd. | 2023 | — |
| +2 | K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph, 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K071955 | Wim-PC, Model 1010Summary page 2…ate Device: 1. WMIB-PC (PulimoTrack 2010), Diagnostic pulmonary-function interpretation calculator; KarmelSonix (K071955). 2. Vasomedical Biox 1305; Medical Magnetic Tape Recorder, Vasomedical,… | 2007 |
| * | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CSummary page 2…calculator; KarmelSonix (K071955). 2. Vasomedical Biox 1305; Medical Magnetic Tape Recorder, Vasomedical, Inc (K(083820). Performance Data: Performance Testing - bench tests The PulmoTrack 5050 Wholter underwen… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110525 | Vitalograph Model 7100 - Vitalojak | 2011 | 5 |
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 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K110525 (Vitalograph (Ireland), Ltd., 2011) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K071955.
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?
The PulmoTrack 5050 WholterTM is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data.
The Pulmo Track 5050 WholterTm is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101022: Pulmotrack 5050 Wholter, Model 5050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101022
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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