510(k) · Cleared
ClearedSwabcap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excelsior Medical Corp. · QBP Cap, Device Disinfectant
Cleared on Apr 28, 2009 as substantially equivalent to K080579 (Hospira, Inc., 2008) and 1 other predicate after a 153-day review. Its family tree reaches back 3 generations to 2003. 23 later devices descend from it.
- Decided
- Apr 28, 2009
- Review
- 153 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K030467 (2003). 5 ancestors in all, the oldest K833182 (1983). 23 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 2 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 1 generation backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- This deviceK083508 SwabcapExcelsior Medical Corp. · 2009
- Descendant · cites it directly · 8 of its ownK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK112791 Sitescrub Ipa DeviceC. R. Bard · 2012
- Descendant · cites it directly · 2 of its ownK130975 Swabcap and SwabflushExcelsior Medical Corp. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK113842 Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K093229Catheter Connections DualcapCatheter Connections, Inc. · 2010 · cites it directly8descendants
- K111992Curos Port ProtectorIvera Medical, Inc. · 2012 · cites it directly6descendants
- K112791Sitescrub Ipa DeviceC. R. Bard · 2012 · cites it directly3descendants
- K130975Swabcap and SwabflushExcelsior Medical Corp. · 2013 · cites it directly2descendants
- K113842Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −2 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −1 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| 0 (this device) | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| +1 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| +1 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| +1 | K112791 | Sitescrub Ipa Device | C. R. Bard | 2012 | — |
| +1 | K130975 | Swabcap and Swabflush | Excelsior Medical Corp. | 2013 | 2 |
| +2 | K113842 | Catheter Connections' Dualcap Solo | Catheter Connections, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K080579 | Effectiv (TM) CapSummary page 5…o Predicate Device: Substantial equivalence is claimed to the following devices as related to intended use and design characteristics: o Effectiv” Cap, Hospira, Inc., K080579 o Curos™ Port Protector, Ivera Medical, K080466 e Alcohol Prep Pad, Professional Disposables Inc. 510(k) Number: Unknown Descr… | 2008 |
| * | K080466 | Alcohol PadSummary page 5…claimed to the following devices as related to intended use and design characteristics: o Effectiv” Cap, Hospira, Inc., K080579 o Curos™ Port Protector, Ivera Medical, K080466 e Alcohol Prep Pad, Professional Disposables Inc. 510(k) Number: Unknown Description of the Device The SwabCap™ is designed to… | 2008 |
| * | — | Alcohol Prep Pad, Professional Disposables Inc. Named without a submission number |
What descends from it? (23)
See all 236 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 6 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K093229 (Catheter Connections, Inc., 2010) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K080579.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
SwabCap™ is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses.
SwabCap™ will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for 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/K083508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083508: Swabcap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083508
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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