# K160082: Puritan Opti-Tranz Cary-Blair Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Medical Products, LLC
- Decided: Jul 29, 2016 after 196 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: 1 generation back to K946286 (1995). 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)
- K946286: Copan Venturi Transystem Cary-Blair Medium, Copan Diagnostics, Inc. (1995) Summary page 4.

## Indications for use
Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

Source page: https://510kreport.com/device/K160082
Methodology: https://510kreport.com/methodology