510(k) Report

510(k) · Cleared

Recalled · 2003

Sandhill Disposable Internal Reference PH Probe

K931963510(k) TraditionalCleared Sep 28, 1994525-day reviewClass I21 CFR 876.1400Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sandhill Scientific, Inc. · FFT Electrode, Ph, Stomach

Cleared on Sep 28, 1994 after a 525-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
Sep 28, 1994
Review
525 days
Class
Class I
Product code
FFT
Recalls
2
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1990200020102020
  1. This deviceK931963 Sandhill Disposable Internal Reference PH ProbeSandhill Scientific, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK013951 Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K013951Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931963Sandhill Disposable Internal Reference PH ProbeSandhill Scientific, Inc.1994—
+1K013951Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K931963, 1994–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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.

NumberDeviceApplicantDecidedDescendants
K013951Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc.20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 24, 2003Not classifiedZ-0104-04OtherPouch containing pediatric probes was labeled as containing adult probes.
Jan 8, 2003Not classifiedZ-0466-03OtherFailure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K013951 (Sandhill Scientific, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FFT devices

FFT Electrode, Ph, Stomach: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFT

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

2007: 12026 (partial year): 1, 1 Class I
2007high 1 (2007) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FFT

590in 2025

2007: 4992008: 8842009: 3362010: 9282011: 1,5062012: 1,7072013: 3142014: 3062015: 3472016: 4722017: 8962018: 9552019: 6212020: 7702021: 5162022: 2602023: 2592024: 2392025: 590
2007high 1,707 (2012) · low 239 (2024)2025

MAUDE reports naming product code FFT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—1499
20080—0884
20090—0336
20101—0928
20110—01,506
20120—01,707
20130—0314
20140—0306
20150—0347
20160—0472
20170—0896
20180—0955
20190—0621
20200—0770
20210—0516
20220—0260
20230—0259
20240—0239
20250—0590
20260—1 (1)—

More from Sandhill Scientific, Inc.

16 FDA decisions under this applicant name. See the company

  • K111013ACEMSandhill Scientific, Inc. · 2011
  • K012232Insight, Model S980000Sandhill Scientific, Inc. · 20022 recalls
  • K013951Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc. · 2002
  • K002427Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026Sandhill Scientific, Inc. · 2001
  • K990441Insight Sphincter of Oddi Manometry Module, Model S981300Sandhill Scientific, Inc. · 1999

Recent decisions in FFT

The FFT category page

  • K102543Bravo PH Monitoring System and AccessoriesGiven Imaging, Ltd. · 20101 Class I recall
  • K013951Sandhill Scientific Pediatec PH ProbeSandhill Scientific, Inc. · 2002
  • K002028Bravo PH Monitoring SystemEndonetics, Inc. · 20004 recalls
  • K961346PH Analysis ModuleSynectics-Dantec · 1997
  • K950087LOT 440Medical Instruments Corporation Mic AG · 1996

https://510kreport.com/device/K931963 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931963: Sandhill Disposable Internal Reference 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/K931963

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026