# K083472: Medegen Pressure Rated Extension Sets

- Pathway: 510(k) (Traditional)
- Applicant: Medegen, Inc.
- Decided: Dec 9, 2008 after 15 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 4 cite it directly.
0 of 33 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
- K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device (2012), 28 descendants of its own
- K132413: MZ1000 (2013), 26 descendants of its own
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own

## Recalls of this device
- Jun 16, 2026 · Class II · Z-2941-2026: Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.
- May 2, 2019 · Class II · Z-0049-2020: After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains pe

## Indications for use
The Medegen Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities, home care and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Medegen Pressure Rated Extension Sets allow the user to add medication into the primary line without the use of a needle. The Medegen Pressure Extension Sets may also be used with low-pressure power injectors rated up to 325 psi.

Source page: https://510kreport.com/device/K083472
Methodology: https://510kreport.com/methodology