510(k) · Cleared
ClearedCuros Port Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivera Medical · QBP Cap, Device Disinfectant
Cleared on Jun 23, 2011 as substantially equivalent to K080466 (122 Corporation, 2008) after a 91-day review. Its family tree reaches back 2 generations to 1983. 7 later devices descend from it.
- Decided
- Jun 23, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K833182 (1983). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK833182 Aplicare Alcohol Prep PadAplicare, Inc. · 1983
- 1 generation backK080466 Alcohol Pad122 Corporation · 2008
- This deviceK110826 Curos Port ProtectorIvera Medical · 2011
- Descendant · cites it directly · 6 of its ownK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK193190 BD PureHub Disinfecting CapBecton, Dickinson and Company · 2020
- Descendant · 3 generations on · 0 of its ownK251592 SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical · 2026
- Descendant · 2 generations on · 0 of its ownK223914 ACTIV™ CapCleansite Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK200299 Curos Jet Disinfecting Cap3M Company · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111992Curos Port ProtectorIvera Medical, Inc. · 2012 · cites it directly6descendants
- K193190BD PureHub Disinfecting CapBecton, Dickinson and Company · 2020 · 2 generations on1descendant
- K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical · 2026 · 3 generations on0descendants
- K223914ACTIV™ CapCleansite Medical, Inc. · 2024 · 2 generations on0descendants
- K200299Curos Jet Disinfecting Cap3M Company · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K833182 | Aplicare Alcohol Prep Pad | Aplicare, Inc. | 1983 | — |
| −1 | K080466 | Alcohol Pad | 122 Corporation | 2008 | — |
| 0 (this device) | K110826 | Curos Port Protector | Ivera Medical | 2011 | — |
| +1 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| +2 | K193190 | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | 2020 | — |
| +3 | K251592 | SteriHub™ Disinfecting Device and Protective Cover | 1World Vista Medical | 2026 | — |
| +2 | K223914 | ACTIV™ Cap | Cleansite Medical, Inc. | 2024 | — |
| +2 | K200299 | Curos Jet Disinfecting Cap | 3M Company | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2020 | 2 | 0 |
| 2024 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K080466 | Alcohol PadSummary page 5…needieless luer activated valves. Common Name: Pad, Alcohol Trade Name: Curos™ Port Protector Classification: Unclassified Device, product Code LKB Predicate Devices K080466 Curos Port Protector Intended Use (Indications) The Ivera Medical Curos™ Part Protector is a device containing 70% Isopropyl Al… | 2008 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111992 | Curos Port Protector | 2012 | 6 |
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 28 years and passes through 3 companies; a new generation was cleared every 25.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111992 (Ivera Medical, Inc., 2012) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K080466.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Curos™ Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the Curos™ Port Protector decontaminates the injection port; thereafter the Curos™ Port Protector provides a physical barrier during the 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/K110826 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110826: Curos Port Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110826
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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