# K112636: Cytoguard (TM) Closed Luer Connector

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 26, 2011 after 78 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
Longest line of descent: 2 generations back to K970855 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070532: Spiros, Icu Medical, Inc. (2007) Summary page 1.
- K082806: Spinning Spiros, Model CH-2000, Icu Medical, Inc. (2009) Summary page 1.
- K051437: CML 1000, Icu Medical, Inc. (2005) Summary page 1.

## Recalls of this device
- Apr 10, 2017 · Class II · Z-2155-2017: B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.

## Indications for use
The CytoGuardTM Closed Luer Connector is a bi-directional flow, needle-free, swabable luer access device used as an accessory to an IV Administration Set. It is intended for the administration of parenteral fluids, medication (including hazardous drugs), blood and blood products. With the CytoGuard attached to the standard male luer of a dosing device or container, the CytoGuard valve is in a closed position. Upon connection of its male luer fitting to the female luer fitting of a patient's administration set or catheter, the valve opens to allow medication delivery to the patient. The fluid path then closes, upon disconnect.

Source page: https://510kreport.com/device/K112636
Methodology: https://510kreport.com/methodology