Diversatek Healthcare Inc
Highlands Ranch, CO, US
DIVERSATEK HEALTHCARE INC appears in FDA device records in Highlands Ranch, CO. FDA records list 20 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Diversatek Healthcare Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Sandhill Scientific, Inc.510(k), recall
510(k) clearance history
FDA records hold 20 510(k) clearances for Diversatek Healthcare Inc between 1984 and 2023. The busiest year on record is 1994, with 4. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 4 |
| 1995 | 1 |
| 1996 | 2 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2011 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230056 | MiVu™ Esophageal Endo Cap | QIS | Substantially Equivalent | |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | OCX | Substantially Equivalent | |
| DEN180067 | Mucosal Integrity Conductivity (MI) Test System | QIS | Unknown | |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | FFX | Substantially Equivalent | |
| K111013 | ACEM | FFZ | Substantially Equivalent | |
| K012232 | INSIGHT, MODEL S980000 | FFX | Substantially Equivalent | |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | FFT | Substantially Equivalent | |
| K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 | FFX | Substantially Equivalent | |
| K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 | FFX | Substantially Equivalent | |
| K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 | FFX | Substantially Equivalent | |
| K961056 | BIOVIEW MODEL S960000 | KLA | Substantially Equivalent | |
| K942247 | SMALL BOWEL ANALYSIS SOFTWARE | FFX | Substantially Equivalent | |
| K941801 | ANALGRAPH | KLA | Substantially Equivalent | |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | FFT | Substantially Equivalent | |
| K926218 | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) | HIR | Substantially Equivalent | |
| K932306 | MICROINFUSOR | FFX | Substantially Equivalent | |
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE | FAP | Substantially Equivalent | |
| K912772 | SUPERLOGGER | FFT | Substantially Equivalent | |
| K904231 | MODEL OSP, SANDHILL AMS | FAD | Substantially Equivalent | |
| K834512 | SANDMILL RMS | FFT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183446 | 2183446 | DIVERSATEK HEALTHCARE INC | 102 EAST KEEFE AVE., Milwaukee, WI 53212 US | 2026 | and 16 more, listed in full below |
| 2023374 | 2023374 | DIVERSATEK HEALTHCARE INC. | 9150 Commerce Center Cir Ste 500, Highlands Ranch, CO 80129 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)
- KDQBottle, Collection, Vacuum
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology
- KTIBronchoscope Accessory
- GBSCatheter, Ventricular, General & Plastic Surgery
- GDJClamp, Surgical, General & Plastic Surgery
- FFZCord, Electric, For Endoscope
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- JXEDevice, Nerve Conduction Velocity Measurement
- KNQDilator, Esophageal
- FFTElectrode, Ph, Stomach
- IKNElectromyograph, Diagnostic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- MNKEndoscopic Bite Block
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- QISEsophageal, Mucosal, Electrical Characterization
- FCLForceps, Biopsy, Non-Electric
- GWQFull-Montage Standard Electroencephalograph
- PKLHemostatic Metal Clip For The Gi Tract
- HIFInsufflator, Laparoscopic
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- HIRPerineometer
- FEQPump, Air, Non-Manual, For Endoscope
- FDGRetractor, Fiberoptic
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- OLVStandard Polysomnograph With Electroencephalograph
- FADStent, Ureteral
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- GWEStimulator, Photic, Evoked Response
- FFXSystem, Gastrointestinal Motility (Electrical)
- HJMTransilluminator, Ac-Powered
- FCHTray, Biopsy, Without Biopsy Instruments
- GAZTubing, Noninvasive
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1941-2026 | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | Class II | Open, Classified | |
| Z-1940-2026 | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18 | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | Class II | Open, Classified | |
| Z-1939-2026 | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | Class II | Open, Classified | |
| Z-1938-2026 | Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08 | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | Class II | Open, Classified | |
| Z-2324-2025 | 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. | Class III | Open, Classified | |
| Z-2521-2023 | 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. | Class III | Open, Classified | |
| Z-1771-2022 | Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract. | M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct. | Class II | Terminated | |
| Z-1487-2012 | 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 documenting and diagnosing digestive motility disorders. | Software error may produce incorrect esophageal contraction readings. | Terminated | ||
| Z-0357-06 | 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 SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'. | 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. | Terminated | ||
| Z-0359-06 | 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. | Terminated | ||
| Z-0356-06 | 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 SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.' | 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. | Terminated | ||
| Z-0104-04 | ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system | Pouch containing pediatric probes was labeled as containing adult probes. | Terminated | ||
| Z-0466-03 | ''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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain