510(k) · Cleared
ClearedAplicare Alcohol Prep Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aplicare, Inc. · LKB Pad, Alcohol, Device Disinfectant
Cleared on Oct 27, 1983 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Oct 27, 1983
- Review
- 38 days
- Class
- Class U
- Product code
- LKB
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 3 citing it directly.
- This deviceK833182 Aplicare Alcohol Prep PadAplicare, Inc. · 1983
- Descendant · cites it directly · 25 of its ownK080466 Alcohol Pad122 Corporation · 2008
- Descendant · 2 generations on · 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 · 7 of its ownK110826 Curos Port ProtectorIvera Medical · 2011
- Descendant · 2 generations on · 6 of its ownK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K080466Alcohol Pad122 Corporation · 2008 · cites it directly25descendants
- K083508SwabcapExcelsior Medical Corp. · 2009 · 2 generations on23descendants
- K093229Catheter Connections DualcapCatheter Connections, Inc. · 2010 · cites it directly8descendants
- K110826Curos Port ProtectorIvera Medical · 2011 · 2 generations on7descendants
- K111992Curos Port ProtectorIvera Medical, Inc. · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K833182 | Aplicare Alcohol Prep Pad | Aplicare, Inc. | 1983 | — |
| +1 | K080466 | Alcohol Pad | 122 Corporation | 2008 | — |
| +2 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| +1 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| +2 | K110826 | Curos Port Protector | Ivera Medical | 2011 | — |
| +2 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 263 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?
- Of its descendants, K080466 (122 Corporation, 2008) has gone furthest, with 25 descendants of its own.
How does its category compare?
All LKB devicesLKB Pad, Alcohol, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKB
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LKB
Too few LKB 510(k)s in any year since 2007 to give a median.
Recalls per year · LKB
5in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKB
14in 2025
MAUDE reports naming product code LKB, 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 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 5 | 6 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 0 | — | 0 | 40 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K833182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K833182: Aplicare Alcohol Prep Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833182
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026