# K961895: Flexilog LS 13921

- Pathway: 510(k) (Traditional)
- Applicant: Oakfield Instruments, Ltd.
- Decided: Nov 4, 1996 after 172 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 II: 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 is used for the location of the lower esophageal sphincter and the measuring of the nares to lower esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.

Source page: https://510kreport.com/device/K961895
Methodology: https://510kreport.com/methodology