# K191564: Progenikine   Concentrating System 25 mL System

- Pathway: 510(k) (Traditional)
- Applicant: Emcyte Corporation
- Decided: Nov 7, 2019 after 147 days
- Product code: MUU (System, Suction, Lipoplasty)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Progenikine Concentrating System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The Progenikine® Concentrating System is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Progenikine Concentrating System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.

Source page: https://510kreport.com/device/K191564
Methodology: https://510kreport.com/methodology