510(k) · Cleared
ClearedVyntus BODY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vyaire Medical, Inc. · BZC Calculator, Pulmonary Function Data
Cleared on Aug 16, 2019 as substantially equivalent to K122699 (Carefusion Germany 234 GmbH, 2012) and 1 other predicate after a 136-day review. Its family tree reaches back 7 generations to 2000. 1 of the 23 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 16, 2019
- Review
- 136 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K002074 (2000). 22 ancestors in all, the oldest K911097 (1991). No later device cites it as a predicate yet. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 6 generations backK070614 CorscreenViasys Healthcare GmbH · 2007
- 5 generations backK080734 Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008
- 4 generations backK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008
- 3 generations backK091505 COR12+Viasys Healthcare GmbH · 2009
- 2 generations backK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- 1 generation backK181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc. · 2018
- This deviceK190853 Vyntus BODYVyaire Medical, Inc. · 2019
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Line2 generations back · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −6 | K070614 | Corscreen | Viasys Healthcare GmbH | 2007 | — |
| −5 | K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CT | Viasys Healthcare GmbH | 2008 | — |
| −4 | K082539 | Masterscope, Masterscope Ecg, Masterscope CT | Cardinal Health Germany 234 GmbH | 2008 | — |
| −3 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| −2 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| −1 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
| 0 (this device) | K190853 | Vyntus BODY | Vyaire Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K122699 | Sentrysuite Product LineSummary page 4…II III. Predicate Device Substantial equivalence is claimed to the following devices: • Primary Predicate: SentrySuite Product Line, K122699, CareFusion Germany 234 GmbH • Secondary Predicate: Vyntus ONE, K181524, Vyaire Medical Inc. IV. Device Des… | 2012 |
| * | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Summary page 4…imed to the following devices: • Primary Predicate: SentrySuite Product Line, K122699, CareFusion Germany 234 GmbH • Secondary Predicate: Vyntus ONE, K181524, Vyaire Medical Inc. IV. Device Description The Vyntus BODY is a whole-bodyplethysmograph and consists of the… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K122699.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 BODY 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 future reference or report generation purposes. The products…
Read the full statement (155 words)
The Vyntus BODY 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 future reference or report generation purposes.
The products can be utilized with patients aged 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).
A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190853 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190853: Vyntus BODY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190853
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