510(k) · Cleared
ClearedSandhill Scientific Pediatec PH Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandhill Scientific, Inc. · FFT Electrode, Ph, Stomach
Cleared on Feb 28, 2002 as substantially equivalent to K931963 (Sandhill Scientific, Inc., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 28, 2002
- Review
- 90 days
- Class
- Class I
- Product code
- FFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931963 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK931963 Sandhill Disposable Internal Reference PH ProbeSandhill Scientific, Inc. · 1994 · Recalled
- This deviceK013951 Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931963 | Sandhill Disposable Internal Reference PH Probe | Sandhill Scientific, Inc. | 1994 | 2 |
| 0 (this device) | K013951 | Sandhill Scientific Pediatec PH Probe | Sandhill Scientific, Inc. | 2002 | — |
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.
Planning a device in FFT? 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 |
|---|---|---|---|
| * | K931963 | Sandhill Disposable Internal Reference PH ProbeSummary page 1…cientific, Inc. H. Substantial Equivalence » This pediatric pH probe is substantially equivalent to the Sandhill Disposable Internal Reference pH probe cleared under K931963/A, September 28, 1994. L. Performance Standard There is currently no performance standard for pH probes. J. Off… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this 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.
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?
Used to measure intragastric and intraesophageal pH (hydrogen ion concentration)
in pediatric patients
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013951: Sandhill Scientific Pediatec PH Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013951
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026