# K983480: Bpos-Ivad Stabilizer

- Pathway: 510(k) (Traditional)
- Applicant: Bpos, Inc.
- Decided: Nov 23, 1998 after 52 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- 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) vein stabilizer: named in the summary without a submission number

## Indications for use
The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.

Source page: https://510kreport.com/device/K983480
Methodology: https://510kreport.com/methodology