# K925161: Nortec Sterile Water for Catheter Balloon Inflatio

- Pathway: 510(k) (Traditional)
- Applicant: North American Sterilization & Packaging Co.
- Decided: Jul 21, 1993 after 281 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K925161
Methodology: https://510kreport.com/methodology