Sandhill Scientific medical diagnostics devices

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Sandhill Scientific, Inc. makes

Sandhill Scientific, Inc. manufactures medical devices for gastrointestinal diagnostics and motility testing, including pH probes for pediatric and internal reference use, motility monitoring systems like the Insight Gastrointestinal Motility System, and specialized manometry modules such as the Sphincter of Oddi Manometry Module. Their portfolio also includes disposable probes, microinfusion systems, and electrode-based diagnostic tools like the Eismann-Tries MEP probe and the Analgraph system for motility analysis.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory clearance obtained through the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

Search and filter all 16 devices

Sandhill Scientific Pediatec Ph Probe Ref K013951

Active Regimes: 510(k) Registry: 510(k) Class:I
Acem Ref K111013

Active Regimes: 510(k) Registry: 510(k) Class:II
Sandmill Rms Ref K834512

Active Regimes: 510(k) Registry: 510(k) Class:I
Microinfusor Ref K932306

Active Regimes: 510(k) Registry: 510(k) Class:II
Insight Gastrointestinal Motility System, Model S980000 Ref K984444

Active Regimes: 510(k) Registry: 510(k) Class:II
Superlogger Ref K912772

Active Regimes: 510(k) Registry: 510(k) Class:I
Sandhill Disposable Internal Reference Ph Probe Ref K931963

Active Regimes: 510(k) Registry: 510(k) Class:I
Insight Sphincter Of Oddi Manometry Module, Model S981300 Ref K990441

Active Regimes: 510(k) Registry: 510(k) Class:II
Eisman-Tries Mep (Multiple Electrode Probe) Ref K926218

Active Regimes: 510(k) Registry: 510(k) Class:II
Insight, Model S980000 Ref K012232 Open recall

Active Regimes: 510(k) Registry: 510(k) Class:II
Analgraph Ref K941801

Active Regimes: 510(k) Registry: 510(k) Class:II
Bioview Model S960000 Ref K961056

Active Regimes: 510(k) Registry: 510(k) Class:II
Small Bowel Analysis Software Ref K942247

Active Regimes: 510(k) Registry: 510(k) Class:II
Schuster Disposable Balloon Probe Ref K931175

Active Regimes: 510(k) Registry: 510(k) Class:II
Model Osp, Sandhill Ams Ref K904231

Active Regimes: 510(k) Registry: 510(k) Class:II
Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026 Ref K002427

Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-16 of 16

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Sandhill Scientific, Inc., the earliest on 2003-01-08 and the most recent on 2009-02-23. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

2009
- 23 Feb 2009 Z-1487-2012 Unclassified (pre-2012) Terminated Software error may produce incorrect esophageal contraction readings. Distribution: Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, FL, IA, IL, MA, MD, MI, MN, NC, ND, NE, NM,…
  Full distribution text
  Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, FL, IA, IL, MA, MD, MI, MN, NC, ND, NE, NM, NY, OH, OR, PA, SC, SD, TX, UT, VA and WA and the countries of Belgium, Canada, Malaysia, Mexico, New Zealand, South-Korea, Switzerland and United Kingdom.
  Submission number: K012232
2005
- 13 Dec 2005 Z-0356-06 Unclassified (pre-2012) Terminated The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol. Distribution: CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO.…
  Full distribution text
  CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO. Foreign distribution to Egypt, Netherlands.
  Submission number: K931175
- 13 Dec 2005 Z-0357-06 Unclassified (pre-2012) Terminated The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol. Distribution: CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO.…
  Full distribution text
  CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO. Foreign distribution to Egypt, Netherlands.
- 13 Dec 2005 Z-0359-06 Unclassified (pre-2012) Terminated Labeling does not indicate that the product contains latex. Distribution: Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO,…
  Full distribution text
  Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO, CT, HI, and NC. Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil.
  Submission number: K931175
2003
- 24 Sep 2003 Z-0104-04 Unclassified (pre-2012) Terminated Pouch containing pediatric probes was labeled as containing adult probes. Distribution: CO, MT, TX. Submission number: K931963
- 8 Jan 2003 Z-0466-03 Unclassified (pre-2012) Terminated Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication. Distribution: Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands,…
  Full distribution text
  Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands, Spain.
  Submission number: K931963

Frequently asked questions

How many devices does Sandhill Scientific, Inc. have in the registry?

The registry currently lists 16 devices for Sandhill Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sandhill Scientific, Inc.'s devices?

Among its 16 most recently registered devices, Sandhill Scientific, Inc. has devices listed in FDA 510(k) (16 devices).

What risk classes do Sandhill Scientific, Inc.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Sandhill Scientific, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sandhill Scientific, Inc.?

FDA recall records list 6 recalls initiated by Sandhill Scientific, Inc., the most recent initiated on 23 Feb 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sandhill Scientific, Inc. in the registry?

The most recently registered devices listed for Sandhill Scientific, Inc. include SANDHILL SCIENTIFIC PEDIATEC PH PROBE, ACEM, SANDMILL RMS and MICROINFUSOR.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

Market reach

What Sandhill Scientific, Inc. makes

Catalogue16

Sandhill Scientific Pediatec Ph Probe Ref K013951

Acem Ref K111013

Sandmill Rms Ref K834512

Microinfusor Ref K932306

Insight Gastrointestinal Motility System, Model S980000 Ref K984444

Superlogger Ref K912772

Sandhill Disposable Internal Reference Ph Probe Ref K931963

Insight Sphincter Of Oddi Manometry Module, Model S981300 Ref K990441

Eisman-Tries Mep (Multiple Electrode Probe) Ref K926218

Insight, Model S980000 Ref K012232 Open recall

Analgraph Ref K941801

Bioview Model S960000 Ref K961056

Small Bowel Analysis Software Ref K942247

Schuster Disposable Balloon Probe Ref K931175

Model Osp, Sandhill Ams Ref K904231

Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026 Ref K002427

FDA recalls6

Frequently asked questions