# K791930: IV Extension Set SL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 26, 1979 after 29 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.
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
- 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
- May 13, 2003 · Not classified · Z-0914-03: IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

Source page: https://510kreport.com/device/K791930
Methodology: https://510kreport.com/methodology