# K051943: Sureflow Safety Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Intrasafe Medical, LLC
- Decided: Oct 4, 2005 after 78 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: 2 generations back to K003225 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040385: Multiport Manifold Set with Swabable Valves, Model 9900, Quest Medical, Inc. (2004) Summary page 1.

## Indications for use
The SureFlow Safety Infusion Device is a device intended to allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an IV. manifold via syringe, gravity or infusion pump. By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks.

Source page: https://510kreport.com/device/K051943
Methodology: https://510kreport.com/methodology