# K201674: Cultura Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 3, 2021 after 257 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- 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 K910526 (1991). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113249: Transport Culture Medium Device, Puritan Medical Products, LLC (2012) Summary page 4.

## Most influential descendants
- K242576: AllTest Viral Transport Medium (2025), 0 descendants of its own
- K232357: Copan Universal Transport Medium (UTM-RT) System (2024), 0 descendants of its own

## Indications for use
The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.

Source page: https://510kreport.com/device/K201674
Methodology: https://510kreport.com/methodology