# K981733: Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: Feb 4, 1999 after 262 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913387 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913387: Digitrapper Mark Iii, Synectics-Dantec (1991) Summary page 1.
- K946322: Polygram Software, Synectics Medical, Inc. (1995) Summary page 1.
- K961346: PH Analysis Module, Synectics-Dantec (1997) Summary page 1.

## Most influential descendants
- K011471: Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober (2002), 0 descendants of its own

## Recalls of this device
- Apr 28, 2004 · Not classified · Z-0924-04: Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.

## Indications for use
The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.

Source page: https://510kreport.com/device/K981733
Methodology: https://510kreport.com/methodology