# K993161: Copan Easy-Swab Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Diagnostics, Inc.
- Decided: Nov 9, 1999 after 48 days
- Product code: JTW (System, Transport, Aerobic)
- Device class: 1
- Regulation: 21 CFR 866.2900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913789 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913789: Aerobic Foam Swab Culturette (R), Bd Becton Dickinson Vacutainer Systems Preanalytic (1991) Summary page 1.

## Recalls of this device
- May 2, 2025 · Class II · Z-1937-2025: Swabs for specimen collection may be prone to breakage during product usage.

## Indications for use
The Copan Easy-Swab Collection and Transport System products are sterile, single-use specimen collection chambers intended to preserve the viability of aerobic microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic bacteria.

Source page: https://510kreport.com/device/K993161
Methodology: https://510kreport.com/methodology