Kimball Solutions Jasper, Inc.
Registration 3008253300FEI 3008253300Jasper, IN
Owner/operator: KIMBALL SOLUTIONS GROUP, LLC
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 22
- Added, last 12 months
- 8
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 22
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| OLZ | Alice PSG ComponentsAutomatic Event Detection Software For Polysomnograph With Electroencephalograph | Class 2 | 21 CFR 882.1400 | — |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular | Class 2 | 21 CFR 870.2900 | — |
| DSA | IntraSight PlusCable, Transducer And Electrode, Patient, (Including Connector)Added Jul 20, 2026 | Class 2 | 21 CFR 870.2900 | — |
| DSA | IntraSight MobileCable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | 21 CFR 870.2900 | — |
| DSK | Computer, Blood-PressureCardiovascular | Class 2 | 21 CFR 870.1110 | — |
| DSK | IntraSight PlusComputer, Blood-PressureAdded Jul 20, 2026 | Class 2 | 21 CFR 870.1110 | — |
| DSK | IntraSight MobileComputer, Blood-Pressure | Class 2 | 21 CFR 870.1110 | — |
| ERL | Hydro Irrigation ConsoleDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceAdded Jun 24, 2026 | Class 2 | 21 CFR 874.4250 | — |
| GWG | Hydro Irrigation ConsoleEndoscope, NeurologicalAdded Jun 24, 2026 | Class 2 | 21 CFR 882.1480 | — |
| OWB | IntraSight PlusInterventional Fluoroscopic X-Ray SystemAdded Jul 20, 2026 | Class 2 | 21 CFR 892.1650 | — |
| OWB | SyncVision SystemInterventional Fluoroscopic X-Ray System | Class 2 | 21 CFR 892.1650 | K190626 |
| MWI | MRPC PORTAL 5000 DESKTOP - INVIVOMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | 21 CFR 870.2300 | — |
and 10 more on your full dossier
What changed
- Jul 20, 2026Listing added: DSA — IntraSight Plus
- Jul 20, 2026Listing added: DSK — IntraSight Plus
- Jun 24, 2026Listing added: ERL — Hydro Irrigation Console
- Jun 24, 2026Listing added: GWG — Hydro Irrigation Console
- Jul 20, 2026Listing added: OWB — IntraSight Plus
- Jun 24, 2026Listing added: EOB — Hydro Irrigation Console
- Jul 20, 2026Listing added: IYO — IntraSight Plus
- Jun 25, 2026Listing added: FOX — Hydro Irrigation Console Pole