# K071579: Pef Tube

- Pathway: 510(k) (Traditional)
- Applicant: N.M. Beale Co., Inc.
- Decided: Nov 20, 2007 after 165 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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. The FDA summary names its predicate without a number.
- (no number) Bard Dreiling Tube: named in the summary without a submission number

## Indications for use
For use in achieving simultaneous access to the stomach and duodenum to allow fluid sampling in procedures such as pancreatic exocrine function testing.

Source page: https://510kreport.com/device/K071579
Methodology: https://510kreport.com/methodology