510(k) · Cleared
ClearedSentry WEB SmartInterp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion Germany 234 GmbH · DQK Computer, Diagnostic, Programmable
Cleared on Sep 16, 2016 as substantially equivalent to K122699 (Carefusion Germany 234 GmbH, 2012) and 2 other predicates after a 270-day review. Its family tree reaches back 6 generations to 2000. 1 of the 24 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 16, 2016
- Review
- 270 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K002074 (2000). 23 ancestors in all, the oldest K911097 (1991). No later device cites it as a predicate yet. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 5 generations backK070614 CorscreenViasys Healthcare GmbH · 2007
- 4 generations backK080734 Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008
- 3 generations backK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008
- 2 generations backK091505 COR12+Viasys Healthcare GmbH · 2009
- 1 generation backK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- This deviceK153654 Sentry WEB SmartInterpCarefusion Germany 234 GmbH · 2016
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Linedirect predicate · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −5 | K070614 | Corscreen | Viasys Healthcare GmbH | 2007 | — |
| −4 | K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CT | Viasys Healthcare GmbH | 2008 | — |
| −3 | K082539 | Masterscope, Masterscope Ecg, Masterscope CT | Cardinal Health Germany 234 GmbH | 2008 | — |
| −2 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| −1 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| 0 (this device) | K153654 | Sentry WEB SmartInterp | Carefusion Germany 234 GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K122699 | Sentrysuite Product LineSummary page 5…Reason for Premarket Notification • New device (evaluation software) 5.9 Legally predicate marketed device • SentrySuite Product Line K122699 Code BTY, BZG, BZC, JEH (CareFusion Germany 234 GmbH) • Vyntus/SentrySuite Product line K150810 Code BZC… | 2012 |
| * | K150810 | Vyntus / SentrySuite Product LineSummary page 5…ice • SentrySuite Product Line K122699 Code BTY, BZG, BZC, JEH (CareFusion Germany 234 GmbH) • Vyntus/SentrySuite Product line K150810 Code BZC, DPS (CareFusion Germany 234 GmbH) • RespiEvents software K012020 Code DQK… | 2015 |
| * | K012020 | Respievents Software IS Event Data Processing Sofware for a PCSummary page 5…any 234 GmbH) • Vyntus/SentrySuite Product line K150810 Code BZC, DPS (CareFusion Germany 234 GmbH) • RespiEvents software K012020 Code DQK (Non-Invasive Monitoring Systems Inc.) 5.10 Device Description Sentry Web SmartInterp is a web appl… | 2001 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 23 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 DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
Sentry WEB SmartInterp is a medical software which is intended to be used as an aid in the evaluation and diagnosis of already measured cardiopulmonary data. Access to data will be realized via network or internet with assigned access rights. Patient population is not assigned as it is defined by the measuring devices itself.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153654: Sentry WEB SmartInterp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153654
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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