510(k) · Cleared
ClearedSitescrub Ipa Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C. R. Bard · LKB Pad, Alcohol, Device Disinfectant
Cleared on Feb 24, 2012 as substantially equivalent to K083508 (Excelsior Medical Corp., 2009) and 1 other predicate after a 151-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- Feb 24, 2012
- Review
- 151 days
- Class
- Class U
- Product code
- LKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K030467 (2003). 6 ancestors in all, the oldest K833182 (1983). 3 later devices descend from it, 2 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 deviceK112791 Sitescrub Ipa DeviceC. R. Bard · 2012
- Descendant · cites it directly · 1 of its ownK121655 BD Alcohol SwabBecton, Dickinson & CO · 2013
- Descendant · cites it directly · 0 of its ownK213955 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company · 2022
- Descendant · 2 generations on · 0 of its ownK132380 Prevantics Device SwabProfessional Disposables International, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K121655BD Alcohol SwabBecton, Dickinson & CO · 2013 · cites it directly1descendant
- K2139550.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company · 2022 · cites it directly0descendants
- K132380Prevantics Device SwabProfessional Disposables International, Inc. · 2014 · 2 generations on0descendants
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) | K112791 | Sitescrub Ipa Device | C. R. Bard | 2012 | — |
| +1 | K121655 | BD Alcohol Swab | Becton, Dickinson & CO | 2013 | — |
| +1 | K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | Becton, Dickinson and Company | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K083508 | SwabcapSummary page 1…Trade Name: SwabCap Classification Name: Pad, Alcohol, Device Disinfectant Premarket Notification: K083508 Manufacturer: Excelsior Medical Corporation (Neptune, NJ) Predicate Devices… | 2009 |
| * | K833182 | Aplicare Alcohol Prep PadSummary page 1…Name: Alcohol Prep Pad Classification Name: Pad, Alcohol, Device Disinfectant Premarket Notification: K833182 Manufacturer: Aplicare, Inc. (Meriden, CT) The subject Site-Scrub… | 1983 |
What descends from it? (3)
2 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 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K121655 (Becton, Dickinson & CO, 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K083508.
How does its category compare?
All LKB devicesLKB Pad, Alcohol, 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 · 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?
The Site-Scrub IPA Device is intended for use on injection ports and female luer hubs as a disinfecting cleaner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112791 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112791: Sitescrub Ipa Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112791
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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