# K131630: Puritan Amies Medium Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Medical Products, LLC
- Decided: Oct 21, 2013 after 139 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: 2 generations back to K854986 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972448: Copan Venturi Transystem Amies Medium Without Charcoal, Copan Italia Spa (1997) Summary page 1.

## Indications for use
Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

Source page: https://510kreport.com/device/K131630
Methodology: https://510kreport.com/methodology