# K964589: Flexilog 3000

- Pathway: 510(k) (Traditional)
- Applicant: Oakfield Instruments, Ltd.
- Decided: Mar 4, 1997 after 109 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) Sandhill Medical Inc Superlogger: named in the summary without a submission number
- (no number) Synectics Medical Inc MicroDigitrapper: named in the summary without a submission number
- (no number) Medical Measurement Systems UPS-2020: named in the summary without a submission number

## Indications for use
The FLEXILOG 3000 system is to be used for the recording, display and analysis of pH and pressure data from the upper gastrointestinal tract in ambulant subjects. It provides information that aids in the diagnosis and management of motility disorders. The FLEXILOG 3000 also has a limited stationary manometry capability to aid sensor placement prior to an ambulatory study.

Source page: https://510kreport.com/device/K964589
Methodology: https://510kreport.com/methodology