# K132380: Prevantics Device Swab

- Pathway: 510(k) (Traditional)
- Applicant: Professional Disposables International, Inc.
- Decided: Aug 27, 2014 after 392 days
- Product code: LKB (Pad, Alcohol, Device Disinfectant)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K030467 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080466: Alcohol Pad, 122 Corporation (2008) Summary page 4.
- K121655: BD Alcohol Swab, Becton, Dickinson & CO (2013) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K132380
Methodology: https://510kreport.com/methodology