510(k) · Cleared
ClearedVyntus/ Sentrysuite Product Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion Germany 234 GmbH · BZC Calculator, Pulmonary Function Data
Cleared on Aug 22, 2014 as substantially equivalent to K072323 (Viasys Healthcare GmbH, 2007) and 2 other predicates after a 242-day review. Its family tree reaches back 3 generations to 1995. 1 of the 18 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Aug 22, 2014
- Review
- 242 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K954140 (1995). 9 ancestors in all, the oldest K936108 (1995). 8 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK954140 Masterscreen IosErich Jaeger GmbH & Co. KG · 1995
- 2 generations backK111053 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2011
- 1 generation backK122699 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012
- This deviceK133925 Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014
- 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 ownK242809 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024
- 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 ownK260242 CPETWise PlatformMedibyt, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK183567 Vyntus/SentrySuite Product LineVyaire Medical · 2019
Showing 5 of 8 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 8 · See all- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · cites it directly5descendants
- K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024 · 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
- K260242CPETWise PlatformMedibyt, Ltd. · 2026 · 2 generations on0descendants
- K183567Vyntus/SentrySuite Product LineVyaire Medical · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | 1995 | — |
| −2 | K111053 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2011 | — |
| −1 | K122699 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2012 | — |
| 0 (this device) | K133925 | Vyntus/ Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2014 | — |
| +1 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +1 | K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024 | — |
| +2 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
| +2 | K260242 | CPETWise Platform | Medibyt, Ltd. | 2026 | — |
| +2 | K183567 | Vyntus/SentrySuite Product Line | Vyaire Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 BZC device
- #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K072323 | Masterscreen & Oxycon CPXSummary page 5…Classification Panel 73 Anesthesiology Part 868 Code BZC 5.8 Reason for Premarket Notification • New device (The CareFusion CPET devices K072323 & K992214 have been revised with new hardware. The software platform SentrySuite has been taken over from SentryS… | 2007 |
| * | K992214 | Oxycon ProSummary page 5…fication Panel 73 Anesthesiology Part 868 Code BZC 5.8 Reason for Premarket Notification • New device (The CareFusion CPET devices K072323 & K992214 have been revised with new hardware. The software platform SentrySuite has been taken over from SentrySuite Produ… | 2000 |
| * | K122699 | Sentrysuite Product LineSummary page 5…es K072323 & K992214 have been revised with new hardware. The software platform SentrySuite has been taken over from SentrySuite Product line with 510(k) K122699) 5.9 Legally predicate marketed devices • MasterScreen CPX K072323 Code BZC • Oxycon Pro… | 2012 |
What descends from it? (8)
2 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 19 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K150810 (Carefusion Germany 234 GmbH, 2015) has gone furthest, with 5 descendants of its own.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · BZC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZC
Too few BZC 510(k)s in any year since 2007 to give a median.
Recalls per year · BZC
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZC
3in 2025
MAUDE reports naming product code BZC, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vyntus/SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. 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 future reference or report generation purposes. The products can be utilized with patients…
Read the full statement (119 words)
The Vyntus/SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. 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 future reference or report generation purposes.
The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient’s sex or height exists.
Measurements will be performed under the direction of a physician in a hospital environment, physician’s office or similar setting (professional healthcare facilities).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133925: Vyntus/ 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/K133925
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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