# K973254: J-Tip Injector

- Pathway: 510(k) (Traditional)
- Applicant: National Medical Products, Inc.
- Decided: Nov 24, 1997 after 87 days
- Product code: KZE (Injector, Fluid, Non-Electrically Powered)
- Device class: 2
- Regulation: 21 CFR 880.5430
- 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 J-Tip Needleless Injector System is used for the subcutaneous administrations of xylocaine or calcimar/calcitonin which are appropriate for the injection using jet injection or needleless injection systems. For subcutaneous injections only. The device serves as an alternative to the subcutaneous delivery of xylocaine or calcimar/calcitonin medications with needle and syringe.

Source page: https://510kreport.com/device/K973254
Methodology: https://510kreport.com/methodology