# K021916: Harmac Huber Needle Safety Device, H2984001

- Pathway: 510(k) (Traditional)
- Applicant: Harmac Medical Products, Inc.
- Decided: Aug 29, 2002 after 79 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K760733 (1976). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950895: Harmac Extension Infusion Set, Harmac Medical Products, Inc. (1995) Summary page 1.
- K973497: Huberloc, Medcare Medical Group, Inc. (1998) Summary page 1.

## Indications for use
The intended use of this device is for the removal of 90 degree winged infusion sets, manufactured by Harmac Medical Products and having a 1-1/2" needle or shorter, from implanted ports and the containment of the used needle until placed in an appropriate sharps container. When used in this manner this device is intended to aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K021916
Methodology: https://510kreport.com/methodology