# K151341: Turbo High-Flow Non-coring Needle

- Pathway: 510(k) (Traditional)
- Applicant: Norfolk Medical
- Decided: Aug 20, 2015 after 93 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863721 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961088: Non-Coring Needle, Arrow Intl., Inc. (1996) Summary page 4.
- K863721: Norfolk Medical Posi-Grip 'Huber Point' Needle, Norfolk Medical Products, Inc. (1986) Summary page 4.

## Indications for use
The Tidal High-Flow Non-coring Needle is intended for the access of totally implantable vascular access ports (VAPs) to administer I.V. fluids, infusions drugs, and other fluids, and for the administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen

Source page: https://510kreport.com/device/K151341
Methodology: https://510kreport.com/methodology