# K811078: Radiation Sterilized Admin. Set

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Jul 2, 1981 after 73 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector (2008), 3 descendants of its own
- K111702: Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe (2012), 2 descendants of its own
- K142011: Solution Set/Extension Set (2014), 1 descendant of its own
- K141019: Amicus Separator System/ Amicus Seperator System;Refurbished (2014), 1 descendant of its own
- K162462: AMICUS Separator System, AMICUS Separator System; Refurbished (2016), 0 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1268-2013: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
- Sep 9, 2010 · Not classified · Z-0149-2011: During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties o
- Dec 15, 2005 · Not classified · Z-0639-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0635-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0645-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0649-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0627-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0628-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0646-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Jul 6, 2005 · Not classified · Z-1101-05: Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
- Oct 17, 2002 · Not classified · Z-0506-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0511-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0514-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0515-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0516-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0513-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0512-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Source page: https://510kreport.com/device/K811078
Methodology: https://510kreport.com/methodology