510(k) · Cleared
ClearedPrevantics Device Swab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Professional Disposables International, Inc. · LKB Pad, Alcohol, Device Disinfectant
Cleared on Aug 27, 2014 as substantially equivalent to K080466 (122 Corporation, 2008) and 1 other predicate after a 392-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Aug 27, 2014
- Review
- 392 days
- Class
- Class U
- Product code
- LKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K030467 (2003). 8 ancestors in all, the oldest K833182 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 5 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 4 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 3 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
- 2 generations backK112791 Sitescrub Ipa DeviceC. R. Bard · 2012
- 1 generation backK121655 BD Alcohol SwabBecton, Dickinson & CO · 2013
- This deviceK132380 Prevantics Device SwabProfessional Disposables International, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −5 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −4 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −3 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| −2 | K112791 | Sitescrub Ipa Device | C. R. Bard | 2012 | — |
| −1 | K121655 | BD Alcohol Swab | Becton, Dickinson & CO | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K080466 | Alcohol PadSummary page 4…ollowing devices as related to intended use and design characteristics: Curos® Port Protector, Ivera Medical Corp. (K080466) BD Alcohol Swab, BD Medical – Medical Surgical Systems (K121655) The Preva… | 2008 |
| * | K121655 | BD Alcohol SwabSummary page 4…stics: Curos® Port Protector, Ivera Medical Corp. (K080466) BD Alcohol Swab, BD Medical – Medical Surgical Systems (K121655) The Prevantics® Device swab is available as a 2 in. x 2 in. swab which con… | 2013 |
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 11 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 4 other devices also cite its predicate K080466.
How does its category compare?
All LKB devicesLKB Pad, Alcohol, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Prevantics® Device swab contains a 3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab is intended
for use to disinfect needleless access sites prior to use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132380: Prevantics Device Swab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132380
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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