# K865060: I.V. Set with Dual-Channel Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 6, 1987 after 44 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 25, 2012 · Not classified · Z-1491-2012: The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in thera
- Sep 29, 2005 · Not classified · Z-0133-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0134-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0135-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Jun 9, 2003 · Not classified · Z-0958-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- May 13, 2003 · Not classified · Z-0936-03: The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL

Source page: https://510kreport.com/device/K865060
Methodology: https://510kreport.com/methodology