510(k) · Cleared
ClearedBD Alcohol Swab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · LKB Pad, Alcohol, Device Disinfectant
Cleared on Mar 20, 2013 as substantially equivalent to K112791 (C. R. Bard, 2012) and 1 other predicate after a 288-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.
- Decided
- Mar 20, 2013
- Review
- 288 days
- Class
- Class U
- Product code
- LKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K030467 (2003). 7 ancestors in all, the oldest K833182 (1983). 1 later device descends from it, 1 citing it directly.
- 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 backK112791 Sitescrub Ipa DeviceC. R. Bard · 2012
- This deviceK121655 BD Alcohol SwabBecton, Dickinson & CO · 2013
- Descendant · cites it directly · 0 of its ownK132380 Prevantics Device SwabProfessional Disposables International, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132380Prevantics Device SwabProfessional Disposables International, Inc. · 2014 · cites it directly0descendants
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 | K112791 | Sitescrub Ipa Device | C. R. Bard | 2012 | — |
| 0 (this device) | K121655 | BD Alcohol Swab | Becton, Dickinson & CO | 2013 | — |
| +1 | K132380 | Prevantics Device Swab | Professional Disposables International, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112791 | Sitescrub Ipa Device | 2012 |
| Kept off the family tree | K111992 | FDA’s K111992 is Curos Port Protector Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
| * | K083508 | SwabcapSummary page 1…cate devices to which substantial equivalence is being claimed: KI 12791- Bard Access Systems'Site-Scrub IPA K] 11992- Ivera Medical Corporation's CurosTM Port Protector K083 508- Excelsior Medical Corporation's SxbabCap Device Description: The BD Alcohol Swab is a single use, sterile device that is satura… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132380 | Prevantics Device Swab | 2014 | 0 |
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 10 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K132380 (Professional Disposables International, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112791.
How does its category compare?
All LKB devicesLKB Pad, Alcohol, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
BD Alcohol Swab is a single use, sterile device containing 70% Isopropyl alcohol. When used for scrubbing for 5 seconds and allowing drying for 5 seconds, the BD Alcohol Swab disinfects needleless access sites prior to use. It may be used in the home or healthcare facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121655: BD Alcohol Swab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121655
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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