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, Inc. · QBP Cap, Device Disinfectant
Cleared on Jan 12, 2012 as substantially equivalent to K080466 (122 Corporation, 2008) and 2 other predicates after a 183-day review. Its family tree reaches back 4 generations to 2003. 6 later devices descend from it.
- Decided
- Jan 12, 2012
- Review
- 183 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K030467 (2003). 7 ancestors in all, the oldest K833182 (1983). 6 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 deviceK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK193190 BD PureHub Disinfecting CapBecton, Dickinson and Company · 2020
- Descendant · 2 generations on · 0 of its ownK251592 SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical · 2026
- Descendant · cites it directly · 0 of its ownK223914 ACTIV™ CapCleansite Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK200299 Curos Jet Disinfecting Cap3M Company · 2020
- Descendant · cites it directly · 0 of its ownK140657 Curos Red Port ProtectorIvera Medical, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193190BD PureHub Disinfecting CapBecton, Dickinson and Company · 2020 · cites it directly1descendant
- K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical · 2026 · 2 generations on0descendants
- K223914ACTIV™ CapCleansite Medical, Inc. · 2024 · cites it directly0descendants
- K200299Curos Jet Disinfecting Cap3M Company · 2020 · cites it directly0descendants
- K140657Curos Red Port ProtectorIvera Medical, Inc. · 2014 · cites it directly0descendants
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) | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| +1 | K193190 | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | 2020 | — |
| +2 | K251592 | SteriHub™ Disinfecting Device and Protective Cover | 1World Vista Medical | 2026 | — |
| +1 | K223914 | ACTIV™ Cap | Cleansite Medical, Inc. | 2024 | — |
| +1 | K200299 | Curos Jet Disinfecting Cap | 3M Company | 2020 | — |
| +1 | K140657 | Curos Red Port Protector | Ivera Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (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 |
|---|---|---|---|
| * | K080466 | Alcohol PadSummary page 5…r needleless luer activated valves Common Name: Pad, Alcohol Trade Name: Curos™ Port Protector Classification: Unclassified Device, product Code LKB Predicate Devices K080466 Curos Port Protector, Ivera Medical Corporation K083508 SwabCap, Excelsior Medical Corporation Intended Use (Indications) The C… | 2008 |
| * | K083508 | SwabcapSummary page 5…cohol Trade Name: Curos™ Port Protector Classification: Unclassified Device, product Code LKB Predicate Devices K080466 Curos Port Protector, Ivera Medical Corporation K083508 SwabCap, Excelsior Medical Corporation Intended Use (Indications) The Curos is intended for use on swab-able luer access valves… | 2009 |
| * | K110826 | Curos Port ProtectorSummary page 6…me Alcohol, disinfecting pad Alcohol, disinfecting Alcohol, disinfecting pad pad Manufacturer Ivera Medical Ivera Medical Excelsior Medical Corporation 510(k) number K110826 K110826 K083508 Regulation Unclassified, Unclassified, Unclassified, number, Preamendment device, Preamendment device, Preamendme… | 2011 |
What descends from it? (6)
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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K193190 (Becton, Dickinson and Company, 2020) has gone furthest, with 1 descendant 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. 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?
The Curos 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. Curos ™ will disinfect the valve three (3) minutes after application and act as a physical barrier to contamination for up to seven (7) days (168 hours) if not removed. The effectiveness of Curos Protectors were tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli and Pseudomonas aeruginosa, Candlda glibrata, Candida albicans and was found to have >4 log reductlon The Curos Port Protector may be used in the home or healthcare facility.
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/K111992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111992: Curos Port Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111992
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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