Data / Medical devices / United States / Diversatek Healthcare Inc.
Diversatek Healthcare Inc.: FDA-registered device maker in Highlands Ranch, CO, United States, 10 510(k) clearances
Diversatek Healthcare Inc. is registered with the FDA (registration 2023374) in Highlands Ranch, CO, United States. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 25, 2023. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2023374
- Address
- 9150 Commerce Center Cir Ste 500, Highlands Ranch, CO, United States, 80129
- Owner or operator
- DIVERSATEK HEALTHCARE (2023374)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 11, 2007
- Registered through
- 2027
- Brand names listed
- Buffer, Cadwell, Clinical Innovations probes, ComforTEC Plus, Greenfield, HRIM, InSight Ultima, Insight G2 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 25, 2023 | K230056 | MiVu Esophageal Endo Cap | QIS | Substantially Equivalent | Diversatek Healthcare | accessdata.fda.gov |
| December 23, 2019 | DEN180067 | Mucosal Integrity Conductivity (MI) Test System | QIS | Unknown | Diversatek Healthcare, Inc. | accessdata.fda.gov |
| October 3, 2019 | K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | FFX | Substantially Equivalent | Diversatek Healthcare | accessdata.fda.gov |
| March 15, 2007 | K062222 | UNITIP HIGH RESOLUTION CATHETER | FFX | Substantially Equivalent | Unisensor AG | accessdata.fda.gov |
| January 7, 2003 | K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 | KLA | Substantially Equivalent | Clinical Innovations, Inc. | accessdata.fda.gov |
| June 7, 2002 | K012232 | INSIGHT, MODEL S980000 | FFX | Substantially Equivalent | Sandhill Scientific, Inc. | accessdata.fda.gov |
| February 28, 2002 | K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | FFT | Substantially Equivalent | Sandhill Scientific, Inc. | accessdata.fda.gov |
| June 11, 1998 | K971214 | KILOWIN | GWE | Substantially Equivalent | Cadwell Laboratories, Inc. | accessdata.fda.gov |
| September 28, 1994 | K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | FFT | Substantially Equivalent | Sandhill Scientific, Inc. | accessdata.fda.gov |
| February 15, 1983 | K823701 | MOTILITY CATHETERS | FFX | Substantially Equivalent | Mui Scientific | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 4, 2025 | 97282 | Class III | Ongoing | Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 | Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date. | accessdata.fda.gov |
| July 25, 2023 | 92854 | Class III | Ongoing | ZVU Functional GI Software, REF: ZVU-3 | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. | accessdata.fda.gov |
| February 23, 2009 | 53340 | Not yet classified | Terminated | Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in docum | Software error may produce incorrect esophageal contraction readings. | accessdata.fda.gov |
| December 13, 2005 | 34222 | Not yet classified | Terminated | Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products. | Labeling does not indicate that the product contains latex. | accessdata.fda.gov |
| December 13, 2005 | 34198 | Not yet classified | Terminated | Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIF | 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. | accessdata.fda.gov |
| September 24, 2003 | 27519 | Not yet classified | Terminated | ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system | Pouch containing pediatric probes was labeled as containing adult probes. | accessdata.fda.gov |
| January 8, 2003 | 25364 | Not yet classified | Terminated | ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually. | Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Gastrointestinal Motility (Electrical)
- All makers of Electrode, Ph, Stomach
- All makers of Monitor, Esophageal Motility, Anorectal Motility, And Tube
- All makers of Stimulator, Photic, Evoked Response
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
Updated August 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.