510(k) · Cleared
Recalled · Class II · 2014Catheter Connections Dualcap Solo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Connections, Inc. · QBP Cap, Device Disinfectant
Cleared on Dec 14, 2012 as substantially equivalent to K113842 (Catheter Connections, Inc., 2012) after a 74-day review. Its family tree reaches back 6 generations to 2003. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 14, 2012
- Review
- 74 days
- Class
- Class II
- Product code
- QBP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K030467 (2003). 9 ancestors in all, the oldest K833182 (1983). 1 later device descends from it, 1 citing it directly.
- 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 backK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
- 1 generation backK113842 Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012
- This deviceK123065 Catheter Connections Dualcap SoloCatheter Connections, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK192382 CapKlenZStar Mountain Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192382CapKlenZStar Mountain Medical, Inc. · 2020 · cites it directly0descendants
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 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| −1 | K113842 | Catheter Connections' Dualcap Solo | Catheter Connections, Inc. | 2012 | — |
| 0 (this device) | K123065 | Catheter Connections Dualcap Solo | Catheter Connections, Inc. | 2012 | — |
| +1 | K192382 | CapKlenZ | Star Mountain Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K113842 | Catheter Connections' Dualcap SoloSummary page 5…ssification Advisory Panel: DualCap Solo™ Unclassified Pad, Alcohol, Device Disinfectant Unclassified LKB General Hospital SPONSOR’S CLEARED DEVICE — DualCap Solo™ (K113842): 510(k) Holder of CLEARED DEVICE Regulation Number: Regulation Classification Name: Regulatory Class: Classification Product… | 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 |
|---|---|---|---|
| K192382 | CapKlenZ | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2014 | Class II | Z-2595-2014 | Packaging | Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K192382 (Star Mountain Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions 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/K123065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123065: Catheter Connections Dualcap Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123065
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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