510(k) · Cleared
ClearedCatheter Connections Dualcap
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 Apr 8, 2010 as substantially equivalent to K083508 (Excelsior Medical Corp., 2009) and 4 other predicates after a 176-day review. Its family tree reaches back 4 generations to 2003. 8 later devices descend from it.
- Decided
- Apr 8, 2010
- Review
- 176 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K030467 (2003). 7 ancestors in all, the oldest K833182 (1983). 8 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 3 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 2 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 1 generation backK083508 SwabcapExcelsior Medical Corp. · 2009
- This deviceK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK113842 Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK142806 DualCapCatheter Connections, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK123065 Catheter Connections Dualcap SoloCatheter Connections, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK192382 CapKlenZStar Mountain Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK151620 Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K113842Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012 · cites it directly2descendants
- K142806DualCapCatheter Connections, Inc. · 2015 · cites it directly1descendant
- K123065Catheter Connections Dualcap SoloCatheter Connections, Inc. · 2012 · 2 generations on1descendant
- K192382CapKlenZStar Mountain Medical, Inc. · 2020 · 3 generations on0descendants
- K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −3 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −2 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −1 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| 0 (this device) | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| +1 | K113842 | Catheter Connections' Dualcap Solo | Catheter Connections, Inc. | 2012 | — |
| +1 | K142806 | DualCap | Catheter Connections, Inc. | 2015 | — |
| +2 | K123065 | Catheter Connections Dualcap Solo | Catheter Connections, Inc. | 2012 | 1 |
| +3 | K192382 | CapKlenZ | Star Mountain Medical, Inc. | 2020 | — |
| +2 | K151620 | Firefly Peritoneal Dialysis Connector Disinfection System | Puracath Medical, Inc. | 2016 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K083508 | SwabcapSummary page 5…IED PREDICATE DEVICES: Substantial equivalence is claimed to the following devices as related to intended use and design characteristics: Trade/Device Name: Swab™ Cap (K083508), Excelsior Medical Corporation Regulation Classification Name: Pad, alcohol, device disinfectant Common/Usual Name: Alcohol Pad… | 2009 |
| * | K080579 | Effectiv (TM) CapSummary page 6…IAL CATHETER CONNECTIONS, INC. Page 27 of 119 510(k} Premarket Notification Submission: CATHETER CONNECTIONS’ DUALCAP™ Trade/Device Name: Effectiv™ Cap (K080579), Hospira, Inc. Regulation Classification Name: Pad, alcohol, device disinfectant Common/Usual Name: Alcohol Pad Classificatio… | 2008 |
| * | K080466 | Alcohol PadSummary page 6…y Panel: General Hospital Regulatory Class: UNCLASSIFIED Classification Product Code: LKB ) Regulation Number: UNCLASSIFIED Trade/Device Name: Curos™ Port Protector (K080466), Ivera Medical Regulation Classification Name: None Common/Usuat Name: Pad, alcoho!, device disinfectant Classification Panel… | 2008 |
| * | K833182 | Aplicare Alcohol Prep PadSummary page 6…ation Panel: " General Hospital Regulatory Class: UNCLASSIFIED Classification Product Code: LKB Regulation Number: None Trade/Device Name: Aplicare Alcohol Prep Pad (K833182}, Aplicare, Inc. Regulation Classification Name: Pad, alcohol, device disinfectant Common/Usual Name: Alcohol Pad Classificati… | 1983 |
| * | K981318 | Dual Luer Lock CapSummary page 6…ation Advisory Panel: General Hospital Regulatory Class: UNCLASSIFIED Classification Product Code: LKB Regulation Number: None Trade/Device Name: Dual Luer Lock Cap (K981318), Baxter Healthcare Corporation, Inc. Regulation Classification Name: Set, Administration, Intravascular Common/Usual Name: Mal… | 1998 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K113842 (Catheter Connections, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K083508.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; 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/K093229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093229: Catheter Connections Dualcap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093229
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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