# K021488: Surecan Safety Huber Needle Infusion Sets

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 8, 2002 after 61 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 K890127 (1989). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993848: Millennium Huber Plus Safety Infusion Set, Millennium Medical Distribution, Inc. (2000) Summary page 1.
- K013394: Liftloc Safety Infusion Set, Specialized Health Products, Inc. (2001) Summary page 2.
- K982805: Introcan Safety IV Catheter, B.Braun Medical, Inc. (1999) Summary page 1.
- K955585: V2 Injection Site, B.Braun Medical, Inc. (1996) Summary page 1.

## Indications for use
The Surecan™ Safety Huber Needle Infusion Set is a passive needlestick prevention device which is designed to minimize inadvertent needlesticks. The device is intended to provide implanted subcutaneous port access, used in conjunction with IV administration of chemotherapy and other injectable drugs and/or to withdraw blood.

Source page: https://510kreport.com/device/K021488
Methodology: https://510kreport.com/methodology