510(k) · Cleared
ClearedAlcohol Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
122 Corporation · QBP Cap, Device Disinfectant
Cleared on Oct 21, 2008 as substantially equivalent to K833182 (Aplicare, Inc., 1983) after a 243-day review. Its family tree reaches back 1 generation to 1983. 25 later devices descend from it.
- Decided
- Oct 21, 2008
- Review
- 243 days
- Class
- Class II
- Product code
- QBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833182 (1983). 25 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK833182 Aplicare Alcohol Prep PadAplicare, Inc. · 1983
- This deviceK080466 Alcohol Pad122 Corporation · 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 · cites it directly · 7 of its ownK110826 Curos Port ProtectorIvera Medical · 2011
- Descendant · cites it directly · 6 of its ownK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK112791 Sitescrub Ipa DeviceC. R. Bard · 2012
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K083508SwabcapExcelsior Medical Corp. · 2009 · cites it directly23descendants
- K093229Catheter Connections DualcapCatheter Connections, Inc. · 2010 · cites it directly8descendants
- K110826Curos Port ProtectorIvera Medical · 2011 · cites it directly7descendants
- K111992Curos Port ProtectorIvera Medical, Inc. · 2012 · cites it directly6descendants
- K112791Sitescrub Ipa DeviceC. R. Bard · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833182 | Aplicare Alcohol Prep Pad | Aplicare, Inc. | 1983 | — |
| 0 (this device) | K080466 | Alcohol Pad | 122 Corporation | 2008 | — |
| +1 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| +1 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| +1 | K110826 | Curos Port Protector | Ivera Medical | 2011 | — |
| +1 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| +2 | K112791 | Sitescrub Ipa Device | C. R. Bard | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 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? (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 |
|---|---|---|---|
| * | K833182 | Aplicare Alcohol Prep PadSummary page 5…ed to decontaminate needleless luer activated valves. Product Name: Curos™ Port Protector Classification: Unclassified Device under product Code LKB Predicate Devices K833182 APLICARE Alcohol Prep Pad Intended Use (Indications) The Curos™ Port Protector is a device containing 70% Isopropyl alcohol. Wh… | 1983 |
What descends from it? (25)
See all 255 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?
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 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/K080466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080466: Alcohol Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080466
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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