# K974295: Byron Medical Aspiration and Infiltration/Irrigation Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Byron Medical
- Decided: Feb 10, 1998 after 88 days
- Product code: KGZ (Accessories, Catheter)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820937 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923201: Endosi Suction Irrigator, Armm, Inc. (1993) Summary page 2.
- K820937: Ackrad Fluid Connecting Set, Ackrad Laboratories (1982) Summary page 2.
- (no number) Disposable Tubing: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K93482: VCI Suction and Irrigation Tubing Sets. Number could not be read Summary page 2.

## Indications for use
The Tubing Indications for use are general surgical fluid, exudate, and soft tissue aspiration and general surgical fluid irrigation/infiltration.

Source page: https://510kreport.com/device/K974295
Methodology: https://510kreport.com/methodology