# K974561: Moistair Fluid Air Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Devices, Inc.
- Decided: Feb 19, 1998 after 76 days
- Product code: KYG (Device, Irrigation, Ocular Surgery)
- Device class: 1
- Regulation: 21 CFR 886.4360
- 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) Grieshaber & Co.: named in the summary without a submission number

## Indications for use
For infusion of fluid and air during vitrectomy.

Source page: https://510kreport.com/device/K974561
Methodology: https://510kreport.com/methodology