# K974829: Non-PVC Fluid Path Port Access Infusion Set (with and Without Injection Set)

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories Co., Ltd.
- Decided: Feb 12, 1998 after 50 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) Kawasumi Laboratories Port Access Infusion Set: named in the summary without a submission number
- (no number) The PRN Noncor Port Infusion Set: named in the summary without a submission number

## Indications for use
INFUSION OF FLUIDS, INCLUDING THOSE CONTAINING MEDICATIONS, FROM A CONTAINER TO A PORT IMPLANTED IN, OR OTHERWISE ATTACHED TO, A PATIENT TO AID IN THE DIAGNOSIS OR TREATMENT OF DISEASE OR OTHER CONDITIONS.

Source page: https://510kreport.com/device/K974829
Methodology: https://510kreport.com/methodology