510(k) · Cleared
ClearedSteriHub™ Disinfecting Device and Protective Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
1World Vista Medical · QBP Cap, Device Disinfectant
Cleared on Feb 11, 2026 as substantially equivalent to K193190 (Becton, Dickinson and Company, 2020) after a 264-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Feb 11, 2026
- Review
- 264 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K030467 (2003). 9 ancestors in all, the oldest K833182 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 5 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 4 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 3 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
- 2 generations backK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- 1 generation backK193190 BD PureHub Disinfecting CapBecton, Dickinson and Company · 2020
- This deviceK251592 SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −5 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −4 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −3 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| −2 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| −1 | K193190 | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | 2020 | — |
| 0 (this device) | K251592 | SteriHub™ Disinfecting Device and Protective Cover | 1World Vista Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 QBP? 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 QBP device
- #1 K252006 OTTO™ Disinfecting Capscore 12.3 · 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? (1)
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.
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 23 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QBP
299in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBP
No recall names QBP since 2007.
Adverse event reports per year · QBP
14in 2025
MAUDE reports naming product code QBP, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 4 | 129 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 4 | 299 | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SteriHub TM Disinf ecting Device and Protective Cover is intended for active disinfection of needleless
connectors.
The SteriHub Disinf ecting Device and Protective Cover provides a physical barrier to contamination for up
to 7 days, if not removed. The SteriHub may be used in the home or healthcare facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251592 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251592: SteriHub™ Disinfecting Device and Protective Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251592
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