# K961457: Subliminator

- Pathway: 510(k) (Traditional)
- Applicant: Healex Products, Inc.
- Decided: Jul 18, 1996 after 93 days
- Product code: EJI (Syringe, Cartridge)
- Device class: 2
- Regulation: 21 CFR 872.6770
- 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. The FDA summary names its predicate without a number.
- (no number) Astra manual injection devices: named in the summary without a submission number
- (no number) Schein manual injection devices: named in the summary without a submission number
- (no number) Monoject manual injection devices: named in the summary without a submission number
- (no number) Cook-Waite manual injection devices: named in the summary without a submission number
- (no number) Septodont manual injection devices: named in the summary without a submission number

## Indications for use
The Subliminator will be packaged in a box and sold to dentists and physicians for the surgeless delivery of local anesthetics (and fluids) into tissues.

Source page: https://510kreport.com/device/K961457
Methodology: https://510kreport.com/methodology