510(k) · Cleared
ClearedMasterscope, Masterscope Ecg, Masterscope CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health Germany 234 GmbH · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Dec 2, 2008 as substantially equivalent to K071753 (Viasys Healthcare GmbH, 2007) and 1 other predicate after a 91-day review. Its family tree reaches back 3 generations to 2000. 1 of the 15 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Dec 2, 2008
- Review
- 91 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002074 (2000). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 2 generations backK070614 CorscreenViasys Healthcare GmbH · 2007
- 1 generation backK080734 Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008
- This deviceK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008
- Descendant · cites it directly · 6 of its ownK091505 COR12+Viasys Healthcare GmbH · 2009
- Descendant · cites it directly · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK202754 MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH · 2021
- Descendant · 2 generations on · 1 of its ownK181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK223629 SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Linecites it directly · 2015
Most influential descendants
Showing 5 of 9 · See all- K091505COR12+Viasys Healthcare GmbH · 2009 · cites it directly6descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · cites it directly5descendants
- K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH · 2021 · cites it directly1descendant
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 2 generations on1descendant
- K223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −2 | K070614 | Corscreen | Viasys Healthcare GmbH | 2007 | — |
| −1 | K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CT | Viasys Healthcare GmbH | 2008 | — |
| 0 (this device) | K082539 | Masterscope, Masterscope Ecg, Masterscope CT | Cardinal Health Germany 234 GmbH | 2008 | — |
| +1 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| +1 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +1 | K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | Eresearchtechnology GmbH | 2021 | — |
| +2 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
| +2 | K223629 | SpiroSphere, SpiroSphereECG, CardioSphere | Eresearchtechnology GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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.
1 device in this family has a Class I recall. 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 BTY device
- #1 K260242 CPETWise Platformscore 13.1 · 5 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 |
|---|---|---|---|
| * | K071753 | Masterscreen Pneumo & MasterscopeSummary page 2…ystem Devices, ECG Part 870 5.8 Reason for Premarket Notification New option to an existing Cardinal Health device. (ECG option for MasterSope K071753) 5.9 Legally predicate marketed devices MasterScope / MasterScreen Pneumo K071753 / Code BTY… | 2007 |
| * | K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CTSummary page 2…gally predicate marketed devices MasterScope / MasterScreen Pneumo K071753 / Code BTY FlowScreen / FlowScreen ECG / FlowScreen CT K080734 / Code BTY, DPS 5.10 Predicate Device Company Cardinal Health Germany 234 GmbH (Owned by Cardinal Health Inc. - ow… | 2008 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K091505 (Viasys Healthcare GmbH, 2009) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K071753.
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients. In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-channel ECG's are…
Read the full statement (323 words)
The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients.
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
MasterScope / MasterScope ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. MasterScope / MasterScope ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel).
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all MasterScope / MasterScope ECG measurements. An interpretation by MasterScope / MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG represent partial qualitative and quantitative Information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082539: Masterscope, Masterscope Ecg, Masterscope CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082539
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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