# K964804: Flexilog LS

- Pathway: 510(k) (Traditional)
- Applicant: Oakfield Instruments, Ltd.
- Decided: Aug 6, 1997 after 250 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- Device class: 2
- Regulation: 21 CFR 876.1725
- 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) RMS Iii: named in the summary without a submission number
- (no number) The LES Locator: named in the summary without a submission number
- (no number) Biolab: named in the summary without a submission number
- (no number) Digitrapper MKIII: named in the summary without a submission number
- (no number) Digitrapper MD: named in the summary without a submission number
- (no number) PC Polygraph HR: named in the summary without a submission number

## Indications for use
The FLEXILOG™ LS, Esophagedl Sphinctor Locator, is to be used for the manometric location of the lower and upper esophageal sphincters. That is the measurement of the distance from the nares to the sphincter.

Source page: https://510kreport.com/device/K964804
Methodology: https://510kreport.com/methodology