# K121032: Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Jun 21, 2012 after 77 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: 4 generations back to K011442 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
3 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110901: Symbiq Infusion and Adminstration Set, Hospira, Inc. (2012) Summary page 1.

## Indications for use
Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. They are intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Sub acute Facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.

Source page: https://510kreport.com/device/K121032
Methodology: https://510kreport.com/methodology