# K082472: Virocult, Model MW950

- Pathway: 510(k) (Abbreviated)
- Applicant: Medical Wire & Equipment Company (Bath), Ltd.
- Decided: Dec 30, 2008 after 124 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
Longest line of descent: 1 generation back to K800832 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800832: Viral Culturette Hank's Bal. Salt Sol., Marion Health & Safety, Inc. (1980) Summary page 1.
- K001780: Copan Viral Transystem, Copan Diagnostics, Inc. (2001) Summary page 2.

## Indications for use
Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.

Source page: https://510kreport.com/device/K082472
Methodology: https://510kreport.com/methodology