# K002028: Bravo PH Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Endonetics, Inc.
- Decided: Sep 29, 2000 after 88 days
- Product code: FFT (Electrode, Ph, Stomach)
- Device class: 1
- Regulation: 21 CFR 876.1400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K102543: Bravo PH Monitoring System and Accessories (2010), 0 descendants of its own

## Recalls of this device
- Apr 15, 2016 · Class II · Z-1620-2016: Potential of an allergic reaction in a patient with nickel sensitivity.
- Apr 15, 2016 · Class II · Z-1619-2016: Potential of an allergic reaction in a patient with nickel sensitivity.
- Dec 3, 2007 · Not classified · Z-0517-2008: Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.
- Feb 6, 2004 · Not classified · Z-0633-04: The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or a

Source page: https://510kreport.com/device/K002028
Methodology: https://510kreport.com/methodology