# K162826: Encore Neutral

- Pathway: 510(k) (Traditional)
- Applicant: Rymed Technologies, LLC
- Decided: Jun 15, 2017 after 251 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942988 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991653: Invision-Plus Injection Port Connector System, Rymed Technologies, Inc. (1999) Summary page 4.

## Indications for use
The Encore™ Neutral is intended for single patient use in intravenous and blood administrations and aspiration without the need for needles, thus eliminating the potential for needle-stick injuries during use. The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The subject device does not have to be changed subsequent to use with a low pressure power injector.

Source page: https://510kreport.com/device/K162826
Methodology: https://510kreport.com/methodology