# K121039: Copan Mswab Collection, Transport and Preservation System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Flock Technologies
- Decided: May 25, 2012 after 50 days
- Product code: JTW (System, Transport, Aerobic)
- 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
Longest line of descent: 3 generations back to K854986 (1986). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061301: Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System, Copan Diagnostics, Inc. (2006) Summary page 1.
- K042970: Copan Universal Transport Medium (Utm-RT) System, Copan Diagnostics, Inc. (2004) Summary page 1.

## Most influential descendants
- K211707: BioTeke Sterile Disposable Virus Sampling Kit (2022), 0 descendants of its own

## Indications for use
MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture.

Source page: https://510kreport.com/device/K121039
Methodology: https://510kreport.com/methodology