510(k) · Cleared
ClearedMasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eresearchtechnology GmbH · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Jan 28, 2021 as substantially equivalent to K082539 (Cardinal Health Germany 234 GmbH, 2008) after a 129-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jan 28, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002074 (2000). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 3 generations backK070614 CorscreenViasys Healthcare GmbH · 2007
- 2 generations backK080734 Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008
- 1 generation backK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008
- This deviceK202754 MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH · 2021
- Descendant · cites it directly · 0 of its ownK223629 SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −3 | K070614 | Corscreen | Viasys Healthcare GmbH | 2007 | — |
| −2 | K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CT | Viasys Healthcare GmbH | 2008 | — |
| −1 | K082539 | Masterscope, Masterscope Ecg, Masterscope CT | Cardinal Health Germany 234 GmbH | 2008 | — |
| 0 (this device) | K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | Eresearchtechnology GmbH | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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.
Planning a device in BTY? 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? (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 |
|---|---|---|---|
| * | K082539 | Masterscope, Masterscope Ecg, Masterscope CTSummary page 5…n New option to an existing eResearchTechnology device 9 Legally predicate marketed device MasterScope / MasterScope ECG / MasterScope CT K082539 Code BTY, DPS Reference device SpiroSphere K173937 Code BTY 10 Predicate D… | 2008 |
| † | K173937 | SpiroSphere | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223629 | SpiroSphere, SpiroSphereECG, CardioSphere | 2024 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K223629 (Eresearchtechnology GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082539.
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. 2021, 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?
MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It 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. A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An…
Read the full statement (157 words)
MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It 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.
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 quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements.
It can be used by physicians in the office or hospital.
The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202754: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202754
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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