# K021999: Gripper Plus Needle

- Pathway: 510(k) (Traditional)
- Applicant: Deltec, Inc.
- Decided: Aug 13, 2002 after 55 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices 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) GRIPPER Needle: named in the summary without a submission number
- (no number) Huber Plus Safety Infusion Set: named in the summary without a submission number

## Most influential descendants
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle (2007), 18 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), 6 descendants of its own
- K230715: Promisemed Safety Huber Needle (2023), 2 descendants of its own
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set (2021), 2 descendants of its own

## Recalls of this device
- Jul 15, 2019 · Class II · Z-0253-2020: Supplier initiated recall of the GRIPPER Needles

## Indications for use
The GRIPPERPLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

Source page: https://510kreport.com/device/K021999
Methodology: https://510kreport.com/methodology