# K013711: Bacti-Swab Dry

- Pathway: 510(k) (Traditional)
- Applicant: Remel Co.
- Decided: Nov 26, 2001 after 19 days
- Product code: LIO (Device, Specimen Collection)
- Device class: 1
- Regulation: 21 CFR 866.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
REMEL's Bacti-Swab™ Dry collection and transport system is comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve for use in collection and transportation of a variety of samples to the laboratory for microbiological examination when dry swab collection is appropriate.

Source page: https://510kreport.com/device/K013711
Methodology: https://510kreport.com/methodology