# K162284: Puritan Fecal Opti-Swab Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Medical Products, LLC
- Decided: Nov 4, 2016 after 81 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: 2 generations back to K946286 (1995). 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)
- K142094: Copan Fecalswab Collection, Transport and Preservation System, Copan Italia Spa (2015) Summary page 4.

## Indications for use
Puritan Fecal Opti-Swab 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/K162284
Methodology: https://510kreport.com/methodology