# K102543: Bravo PH Monitoring System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Dec 1, 2010 after 89 days
- Product code: FFT (Electrode, Ph, Stomach)
- Device class: 1
- Regulation: 21 CFR 876.1400
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002028 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002028: Bravo PH Monitoring System, Endonetics, Inc. (2000) Summary page 1.

## Recalls of this device
- Jun 3, 2025 · Class I · Z-2047-2025: It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the
- Feb 26, 2021 · Class II · Z-1334-2021: The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is re
- Feb 26, 2021 · Class II · Z-1335-2021: The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is re
- Jan 11, 2012 · Not classified · Z-0966-2012: Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.

## Indications for use
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.

Source page: https://510kreport.com/device/K102543
Methodology: https://510kreport.com/methodology