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 May 10, 2012 as substantially equivalent to K111053 (Carefusion Germany 234 GmbH, 2011) and 1 other predicate after a 139-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 10, 2012
- Review
- 139 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954140 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | 1995 | — |
| −1 | K111053 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2011 | — |
| 0 (this device) | K113813 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K111053 | Sentrysuite Product LineSummary page 2…for the device MasterScreen PFT K072061 by adding it to the SentrySuite Product Line. 5.9 Legally predicate marketed device SentrySuite Product Line K1 11053 Code BTY, BZC, BZG MasterScreen PFT K072061 Code JEH 5.10 Predicate Device Company CareFusion Germany 234 G… | 2011 |
| * | K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodySummary page 2…cation --Modification of legally marketed devices-- Change from previously JLAB software to SentrySuite software for the device MasterScreen PFT K072061 by adding it to the SentrySuite Product Line. 5.9 Legally predicate marketed device SentrySuite Product Line K1 11053… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K111053.
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. 2012, 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/K113813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113813: 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/K113813
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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