510(k) Report

FDA applicant

Sandhill Scientific, Inc.

Littleton, CO16 decisions1984–20116 recalls

FDA records 16 decisions for Sandhill Scientific, Inc. (Littleton, CO) from 1984 to 2011: 16 510(k) clearances. Most are in product codes FFX (System, Gastrointestinal Motility (Electrical)) and FFT (Electrode, Ph, Stomach). Its devices cite 7 predicates, 3 of them its own earlier devices. 6 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Sandhill Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2009: 12023: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sandhill Scientific, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sandhill Scientific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FFXSystem, Gastrointestinal Motility (Electrical)6decisions
  • FFTElectrode, Ph, Stomach4decisions
  • KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2decisions
  • FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device1decision
  • HIRPerineometer1decision
  • FFZCord, Electric, For Endoscope1decision

Also: FAD (1).

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012232Insight, Model S980000Sandhill Scientific, Inc. · 20023cite it
  • K932306MicroinfusorSandhill Scientific, Inc. · 19941cites it
  • K984444Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc. · 19991cites it
  • K931963Sandhill Disposable Internal Reference PH ProbeSandhill Scientific, Inc. · 19941cites it
  • K961056Bioview Model S960000Sandhill Scientific, Inc. · 19961cites it

What has FDA decided for it lately?

  • 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
  • K984444Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc. · 1999
  • K961056Bioview Model S960000Sandhill Scientific, Inc. · 1996
  • K942247Small Bowel Analysis SoftwareSandhill Scientific, Inc. · 1996

All 16 as Sandhill Scientific, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K012232ZVU Functional GI Software, REF: ZVU-3Jul 25, 2023Class III
  • K012232Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use…Feb 23, 2009
  • K931175Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no…Dec 13, 2005
  • K931175Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part…Dec 13, 2005
  • K931963ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility…Sep 24, 2003
  • K931963''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged…Jan 8, 2003

Other applicant names beginning “Sandhill”

FDA records each applicant name separately; these may or may not be the same firm.

Sandhill 3