510(k) · Cleared
ClearedModification to Flowscreen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare GmbH · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on May 11, 2007 after a 298-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 12 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- May 11, 2007
- Review
- 298 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- This deviceK062011 Modification to FlowscreenViasys Healthcare GmbH · 2007
- Descendant · cites it directly · 10 of its ownK080734 Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008
- Descendant · 2 generations on · 9 of its ownK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008
- Descendant · 3 generations on · 6 of its ownK091505 COR12+Viasys Healthcare GmbH · 2009
- Descendant · 3 generations on · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK202754 MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Line3 generations on · 2015
Most influential descendants
Showing 5 of 11 · See all- K080734Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008 · cites it directly10descendants
- K082539Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008 · 2 generations on9descendants
- K091505COR12+Viasys Healthcare GmbH · 2009 · 3 generations on6descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 3 generations on5descendants
- K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062011 | Modification to Flowscreen | Viasys Healthcare GmbH | 2007 | — |
| +1 | K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CT | Viasys Healthcare GmbH | 2008 | — |
| +2 | K082539 | Masterscope, Masterscope Ecg, Masterscope CT | Cardinal Health Germany 234 GmbH | 2008 | — |
| +3 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| +3 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +3 | K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | Eresearchtechnology GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CT | 2008 | 10 |
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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K080734 (Viasys Healthcare GmbH, 2008) has gone furthest, with 10 descendants of its own.
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. 2007, 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 FlowScreen is a diagnostic system for recording and assessing inspiratory and
expiratory pulmonary function (spirometry).
Measurements will be performed under the direction of a physician in the clinic, doctor's
office or hospital. It can be utilized for patients from 4 years on and older as long as they can
cooperate in the performance.
The FlowScreen is powered from 115V/6OHz wall outlets. No energy is transferred to the
patient.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062011: Modification to Flowscreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062011
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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