510(k) · Cleared
ClearedSentrysuite Product Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion Germany 234 GmbH · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Aug 12, 2011 as substantially equivalent to K071753 (Viasys Healthcare GmbH, 2007) and 2 other predicates after a 119-day review. Its family tree reaches back 1 generation to 1995. 1 of the 15 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Aug 12, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954140 (1995). 3 ancestors in all. 11 later devices descend from it, 2 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK954140 Masterscreen IosErich Jaeger GmbH & Co. KG · 1995
- This deviceK111053 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2011
- Descendant · cites it directly · 9 of its ownK122699 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012
- Descendant · 2 generations on · 8 of its ownK133925 Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014
- 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 ownK242809 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024
- Descendant · 4 generations on · 1 of its ownK181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc. · 2018
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- K122699Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012 · cites it directly9descendants
- K133925Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014 · 2 generations on8descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 3 generations on5descendants
- K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024 · 3 generations on1descendant
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | 1995 | — |
| 0 (this device) | K111053 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2011 | — |
| +1 | K122699 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2012 | — |
| +2 | K133925 | Vyntus/ Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2014 | — |
| +3 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +3 | K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024 | — |
| +4 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (3)
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…SentrySuite software for the devices MasterScreen Pneumo, MasterScreen IOS, APS Pro 5.9 Legally predicate marketed device MasterSreen Pneumo K071753 Code BTY MasterScreen lOS K954140 Code BZG APS Pro K001 502 Code BZC 5.10 Predica… | 2007 |
| * | K954140 | Masterscreen IosSummary page 2…rScreen Pneumo, MasterScreen IOS, APS Pro 5.9 Legally predicate marketed device MasterSreen Pneumo K071753 Code BTY MasterScreen lOS K954140 Code BZG APS Pro K001 502 Code BZC 5.10 Predicate Device Company CareFusion Germany 234 G… | 1995 |
| * | K001502 | Aerosol Provocation System Aps Pro, Model Aps ProSummary page 2…Legally predicate marketed device MasterSreen Pneumo K071753 Code BTY MasterScreen lOS K954140 Code BZG APS Pro K001 502 Code BZC 5.10 Predicate Device Company CareFusion Germany 234 GmbH 5.11 Device Description The Sentry… | 2000 |
What descends from it? (11)
See all 112 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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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. 2011, 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 SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes.…
Read the full statement (142 words)
The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes.
Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine.
The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height.
Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111053: Sentrysuite Product Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111053
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