# K071998: Arrow Echogenic Introducer Needle Component

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: Sep 26, 2007 after 65 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810675 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
3 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040100: Arrow Echogenic Introducer Needle, Arrow Intl., Inc. (2004) Summary page 1.
- K924338: Arrow-Fischell Extended Vascular Access Needle, Arrow Intl., Inc. (1993) Summary page 1.
- K021120: Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP, Arrow Intl., Inc. (2002) Summary page 1.
- K003006: Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection, Arrow Intl., Inc. (2000) Summary page 1.

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2022-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1959-2018: Product sterility may be compromised due to unsealed packaging.

## Indications for use
The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.

Source page: https://510kreport.com/device/K071998
Methodology: https://510kreport.com/methodology