510(k) · Cleared
Recalled · Class I · 2025Bravo PH Monitoring System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Given Imaging, Ltd. · FFT Electrode, Ph, Stomach
Cleared on Dec 1, 2010 as substantially equivalent to K002028 (Endonetics, Inc., 2000) after an 89-day review. Its family tree reaches back 1 generation to 2000. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 4 times, including a Class I recall.
- Decided
- Dec 1, 2010
- Review
- 89 days
- Class
- Class I
- Product code
- FFT
- Recalls
- 4 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002028 (2000). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK002028 Bravo PH Monitoring SystemEndonetics, Inc. · 2000 · Recalled
- This deviceK102543 Bravo PH Monitoring System and AccessoriesGiven Imaging, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002028 | Bravo PH Monitoring System | Endonetics, Inc. | 2000 | 4 |
| 0 (this device) | K102543 | Bravo PH Monitoring System and Accessories | Given Imaging, Ltd. | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002028 | Bravo PH Monitoring SystemSummary page 1…Panel: Gastroenterology FFT - Stomach pH electrode Predicate Device(s): Bravo pH- Monitoring SystemuTm and Accessories (K002028) General Device The Bravo pH Monitoring SysteMm and Accessories is an Description: ambulator… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2025 | Class I | Z-2047-2025 | Process control | 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 patient's esophagus or detaching from… |
| Feb 26, 2021 | Class II | Z-1334-2021 | Process change control | 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 required. Potential outcomes following… |
| Feb 26, 2021 | Class II | Z-1335-2021 | Process change control | 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 required. Potential outcomes following… |
| Jan 11, 2012 | Not classified | Z-0966-2012 | Nonconforming Material/Component | Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All FFT devicesFFT Electrode, Ph, Stomach: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FFT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · FFT
Too few FFT 510(k)s in any year since 2007 to give a median.
Recalls per year · FFT
1in 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FFT
590in 2025
MAUDE reports naming product code FFT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 499 |
| 2008 | 0 | — | 0 | 884 |
| 2009 | 0 | — | 0 | 336 |
| 2010 | 1 | — | 0 | 928 |
| 2011 | 0 | — | 0 | 1,506 |
| 2012 | 0 | — | 0 | 1,707 |
| 2013 | 0 | — | 0 | 314 |
| 2014 | 0 | — | 0 | 306 |
| 2015 | 0 | — | 0 | 347 |
| 2016 | 0 | — | 0 | 472 |
| 2017 | 0 | — | 0 | 896 |
| 2018 | 0 | — | 0 | 955 |
| 2019 | 0 | — | 0 | 621 |
| 2020 | 0 | — | 0 | 770 |
| 2021 | 0 | — | 0 | 516 |
| 2022 | 0 | — | 0 | 260 |
| 2023 | 0 | — | 0 | 259 |
| 2024 | 0 | — | 0 | 239 |
| 2025 | 0 | — | 0 | 590 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102543: Bravo PH Monitoring System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102543
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026