# K990510: JMS Apheresis Needle

- Pathway: 510(k) (Traditional)
- Applicant: Jms Co., Ltd.
- Decided: Aug 30, 1999 after 193 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended to provide access to a patient's blood for Apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick Device, use for prevention of needlestick injury a the time of needle withdrawal after usage.

Source page: https://510kreport.com/device/K990510
Methodology: https://510kreport.com/methodology