# K011336: Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock

- Pathway: 510(k) (Traditional)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Jun 12, 2001 after 41 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093271: Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration Set ( Standard (2010), 0 descendants of its own

## Recalls of this device
- Nov 16, 2010 · Not classified · Z-1324-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1322-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1332-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1329-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1319-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1328-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1321-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1320-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Oct 20, 2009 · Not classified · Z-1639-2010: Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents

Source page: https://510kreport.com/device/K011336
Methodology: https://510kreport.com/methodology