# K974288: Zerowet Splashield

- Pathway: 510(k) (Traditional)
- Applicant: Zerowet, Inc.
- Decided: Jan 29, 1998 after 76 days
- Product code: KYZ (Syringe, Irrigating (Non Dental))
- Device class: 1
- Regulation: 21 CFR 880.6960
- 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) Zerowet Splashield (sterile): named in the summary without a submission number

## Indications for use
The Zerowet Splashield is intended for use as an accessory to an irrigation syringe. It is intended to be attached to the end of said syringe during wound irrigation, in place of the commonly used needle, thereby eliminating the use of a needle during this procedure. Additionally, the Zerowet Splashield protects the user from contaminated (bloody) fluid splashing back during wound irrigation.

Source page: https://510kreport.com/device/K974288
Methodology: https://510kreport.com/methodology