# K971901: Radius Low Profile Gastrostomy Tube Kit

- Pathway: 510(k) (Traditional)
- Applicant: Radius Intl., Inc.
- Decided: Jan 22, 1998 after 244 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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) Bard Button Replacement Gastrostomy Device: named in the summary without a submission number

## Indications for use
The device is indicated for percutaneous placement of a low-profile long term gastrostomy feeding and decompression device through an established stoma.

Source page: https://510kreport.com/device/K971901
Methodology: https://510kreport.com/methodology