# K021395: Modification to 30 Extension Set

- Pathway: 510(k) (Special)
- Applicant: Churchill Medical Systems, Inc.
- Decided: May 13, 2002 after 11 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 18 (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’s file for it is a 510(k) statement, which names no predicate.

## 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
- Feb 20, 2017 · Class II · Z-1484-2017: Incorrect priming volume printed on the device package.
- Nov 18, 2016 · Class II · Z-0787-2017: Incorrect priming volume is printed on the device package.
- Jan 15, 2015 · Class II · Z-1472-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1474-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1470-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1475-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1473-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1467-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1477-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1468-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1478-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1471-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1476-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1469-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 7, 2014 · Class II · Z-0813-2014: Defective component may cause extension sets to leak.
- Nov 16, 2010 · Not classified · Z-1325-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1326-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- Nov 16, 2010 · Not classified · Z-1330-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

## Indications for use
The Churchill Medical Systems Extension Sets is an accessory device used to deliver medical fluids.

Source page: https://510kreport.com/device/K021395
Methodology: https://510kreport.com/methodology