510(k) · Cleared
Recalled · Class II · 2016Bravo PH Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endonetics, Inc. · FFT Electrode, Ph, Stomach
Cleared on Sep 29, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Sep 29, 2000
- Review
- 88 days
- Class
- Class I
- Product code
- FFT
- Recalls
- 4
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK002028 Bravo PH Monitoring SystemEndonetics, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK102543 Bravo PH Monitoring System and AccessoriesGiven Imaging, Ltd. · 2010 · Recalled (Class I)
Class I recalls in this family
- K102543 Bravo PH Monitoring System and Accessoriescites it directly · 2010
Most influential descendants
Showing 1 of 1 · See all- K102543Bravo PH Monitoring System and AccessoriesGiven Imaging, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002028 | Bravo PH Monitoring System | Endonetics, Inc. | 2000 | — |
| +1 | K102543 | Bravo PH Monitoring System and Accessories | Given Imaging, Ltd. | 2010 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102543 | Bravo PH Monitoring System and Accessories Class I | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2016 | Class II | Z-1620-2016 | Device Design | Potential of an allergic reaction in a patient with nickel sensitivity. |
| Apr 15, 2016 | Class II | Z-1619-2016 | Device Design | Potential of an allergic reaction in a patient with nickel sensitivity. |
| Dec 3, 2007 | Not classified | Z-0517-2008 | Labeling Change Control | 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 | Other | 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 attributed to the wrong patient. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102543Bravo PH Monitoring System and AccessoriesGiven Imaging, Ltd. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K102543 (Given Imaging, Ltd., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FFT devicesFFT Electrode, Ph, Stomach: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K002028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002028: Bravo PH Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002028
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026