# K980078: Penetrease

- Pathway: 510(k) (Traditional)
- Applicant: P.T. Panca Pusaka Deli
- Decided: Oct 16, 1998 after 281 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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
A device intended for medical purposes used to inject fluids into, or withdraw fluids from, the body that consists of calibrated hollow barrel and a movable plunger, At one end of barrel there is a male connector (nozzle) for fitting the female connector (Hub) of a hypodermic single lumen needle.

Source page: https://510kreport.com/device/K980078
Methodology: https://510kreport.com/methodology