# K972469: Selfshield HN Self Sheathing Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Beech Medical Products, Inc.
- Decided: Aug 27, 1997 after 57 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
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) Sherwood Monoject® Safety Syringe (1, 3, 6 and 12 cc sizes): named in the summary without a submission number

## Indications for use
The SELFSHIELD HN™ Self Sheathing Hypodermic Needle is indicated for non - patient contacting and non-skin penetrating applications such as fluid transfer from a drug vial or ampoule to an IV administration set injection site (Y-site) or an IV catheter intermittent injection cap (heparin lock).

Source page: https://510kreport.com/device/K972469
Methodology: https://510kreport.com/methodology