# K935642: Evans Medical Extension Sets

- Pathway: 510(k) (Traditional)
- Applicant: Evans Medical, Inc.
- Decided: Jan 28, 1994 after 67 days
- Product code: FPK (Tubing, Fluid Delivery)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Mar 15, 2006 · Not classified · Z-0864-06: There exists a possibility that the Pain Management Procedural Trays may contain extension sets that do not meet USP specification requirements for non pyrogenicity (less than or equal to 2.25 EU/devi

Source page: https://510kreport.com/device/K935642
Methodology: https://510kreport.com/methodology