# K964637: Culture Collection and Transport System, Modified Amies Media

- Pathway: 510(k) (Traditional)
- Applicant: Medical Packaging Corp.
- Decided: Dec 24, 1996 after 35 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 K881105 (1988). 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)
- K881105: Culture Collection Device, Medical Packaging Corp. (1988) Summary page 1.
- K932337: Culture-Pak Collection and Transport System, Medical Packaging Corp. (1994) Summary page 1.
- K936078: Culture-Pak Collection/Transport System, Modified, Medical Packaging Corp. (1994) Summary page 1.

## Most influential descendants
- K970597: Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option) (1997), 1 descendant of its own
- K972726: Snap Swab Culture Collection and Transport System (1997), 0 descendants of its own

## Indications for use
Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.

Source page: https://510kreport.com/device/K964637
Methodology: https://510kreport.com/methodology