# K023668: JMS Extension Set with Planecta, Planecta (Stand Alone Unit), Planecta Lock & Planecta Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Jms North America Corp.
- Decided: Jul 1, 2003 after 243 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K070143: JMS Planecta Stopcock (2007), 0 descendants of its own

## Indications for use
JMS Extension Set with PlanectaTM,PlanectaTM(stand alone unit) and PlanectaTMLock / Adaptor are accessories and to be used with a primary vascular access device for fluid administration and blood sampling. PlanectaTMwill be connected with a luer slip syringe or male luer connector to allow needle-less access to the vascular path for injection or withdrawal of fluids or blood. PlanectaTMLock I Adaptor will be used as an adaptor for connection with her lock syringe or other lock-connecting devices. These device accessories are intended for single use only. JMS Extension Set with PlanectaTM,PlanectaTM(stand alone unit) and PlanectaTMLock I Adaptor will reduce the risk of accidental needle stick injury as a needle will not be used or requrlred throughout the procedure for injection or withdrawal of fluid.

Source page: https://510kreport.com/device/K023668
Methodology: https://510kreport.com/methodology