510(k) · Cleared
ClearedCuros Tip
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 Nov 26, 2012 as substantially equivalent to K111992 (Ivera Medical, Inc., 2012) and 1 other predicate after a 223-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Nov 26, 2012
- Review
- 223 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K030467 (2003). 10 ancestors in all, the oldest K833182 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 4 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 3 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 2 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
- 1 generation backK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
- This deviceK121171 Curos TipIvera Medical, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −4 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −3 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −2 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| −1 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| 0 (this device) | K121171 | Curos Tip | Ivera Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111992 | Curos Port ProtectorSummary page 5…ed in the home or healthcare facility. Common Name: Pad, Alcohol Trade Name: Curos Tips™ . Classification: . Unclassified Device, product Code LKB Predicate Devices K111992 Curos Port Protector, Ivera Medical Corporation K093229 Catheter Connections Dual Cap Intended Use (Indications) The Curos Tip… | 2012 |
| * | K093229 | Catheter Connections DualcapSummary page 5…Alcohol Trade Name: Curos Tips™ . Classification: . Unclassified Device, product Code LKB Predicate Devices K111992 Curos Port Protector, Ivera Medical Corporation K093229 Catheter Connections Dual Cap Intended Use (Indications) The Curos Tips™ are intended for use as a disinfecting cleaner for mal… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 4 other devices also cite its predicate K111992.
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 Tips™ are intended for use as a disinfecting cleaner for male luer connectors. Curos Tips will disinfect the male luer (3) minutes after application and will cover the luer until removed. The effectiveness of the Curos Tips was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Tips 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/K121171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121171: Curos Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121171
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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