510(k) · Cleared
ClearedBD PureHub Disinfecting Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · QBP Cap, Device Disinfectant
Cleared on Nov 9, 2020 as substantially equivalent to K111992 (Ivera Medical, Inc., 2012) after a 356-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.
- Decided
- Nov 9, 2020
- Review
- 356 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K030467 (2003). 8 ancestors in all, the oldest K833182 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 4 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 3 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 2 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
- 1 generation backK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- This deviceK193190 BD PureHub Disinfecting CapBecton, Dickinson and Company · 2020
- Descendant · cites it directly · 0 of its ownK251592 SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical · 2026
Most influential descendants
Showing 1 of 1 · See all- K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −4 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −3 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −2 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| −1 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| 0 (this device) | K193190 | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 K251592 SteriHub™ Disinfecting Device and Protective…score 12.3 · 6 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111992 | Curos Port ProtectorSummary page 5…Classification Panel: General Hospital Predicate Device Trade Name: Curos™ Port Protector 510(k) Reference: K111992 Common Name: Cap, Device Disinfectant Regulation Number: Uncl… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251592 | SteriHub™ Disinfecting Device and Protective Cover | 2026 | 0 |
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 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K251592 (1World Vista Medical, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K111992.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses.
BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193190: BD PureHub Disinfecting Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193190
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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