510(k) · Cleared
ClearedEffectiv (TM) Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · QBP Cap, Device Disinfectant
Cleared on Sep 11, 2008 as substantially equivalent to K063239 (Hospira, Inc., 2006) after a 192-day review. Its family tree reaches back 2 generations to 2003. 24 later devices descend from it.
- Decided
- Sep 11, 2008
- Review
- 192 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K030467 (2003). 24 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 1 generation backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- This deviceK080579 Effectiv (TM) CapHospira, Inc. · 2008
- Descendant · cites it directly · 23 of its ownK083508 SwabcapExcelsior Medical Corp. · 2009
- Descendant · cites it directly · 8 of its ownK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
- Descendant · 2 generations on · 6 of its ownK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK112791 Sitescrub Ipa DeviceC. R. Bard · 2012
- Descendant · 2 generations on · 2 of its ownK130975 Swabcap and SwabflushExcelsior Medical Corp. · 2013 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K083508SwabcapExcelsior Medical Corp. · 2009 · cites it directly23descendants
- K093229Catheter Connections DualcapCatheter Connections, Inc. · 2010 · cites it directly8descendants
- K111992Curos Port ProtectorIvera Medical, Inc. · 2012 · 2 generations on6descendants
- K112791Sitescrub Ipa DeviceC. R. Bard · 2012 · 2 generations on3descendants
- K130975Swabcap and SwabflushExcelsior Medical Corp. · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −1 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| 0 (this device) | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| +1 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| +1 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| +2 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| +2 | K112791 | Sitescrub Ipa Device | C. R. Bard | 2012 | — |
| +2 | K130975 | Swabcap and Swabflush | Excelsior Medical Corp. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K033182 | FDA’s K033182 is Prizm Keratome Blade (B.D. Model), Model MK8530BD Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…Summary page 5…tiv™ Cap Proposed Devlce: 5. Predicate Devices: Device Name | 510{k) Number -Alcohol Swab - Aplicars, In¢. KB33182 Lifeshiled Gravitech Flow Set (with cap) - Hospira K063239 6. Proposed Device Description: The Effectiv™ Cap is a cap that holds a sponge soaked with 70% Isopropyl Alcohol {IPA). The cap… | 2006 |
What descends from it? (24)
See all 242 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 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K083508 (Excelsior Medical Corp., 2009) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K063239.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Effectiv™ Cap is a device containing 70% Isopropyl alcohol. When left in place for 5 to 10 minutes the cap decontaminates the injection port; thereafter the cap provides a physical barrier during intended use.
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/K080579 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080579: Effectiv (TM) Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080579
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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