Illinois FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a Illinois address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
13 clearances in the last 90 days. The same 90 days a year earlier: 13.
For contract manufacturers and test labs
Illinois had 13 US 510(k) clearances in the last 90 days and 58 in the last 12 months. The product code with the most clearances in this window is DXN (System, Measurement, Blood-Pressure, Non-Invasive). Contract manufacturers and test labs that sell to device companies in Illinois can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
EBF | Material, Tooth Shade, Resin | 1 |
FMF | Syringe, Piston | 1 |
FPA | Set, Administration, Intravascular | 1 |
JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 23, 2026 | LuxCreo, Inc. | LuxDesign | K260421 |
| Oct 21, 2026 | Sol-Millennium Medical, Inc. | Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set | K260857 |
| Sep 25, 2026 | SimBioSys, Inc. | TumorSight Risk | K260023 |
| Sep 25, 2026 | Tempus AI, Inc. | Tempus ECG-MR | K254297 |
| Sep 23, 2026 | Abbott Laboratories | Anti-HCV Next | K262156 |
| Sep 18, 2026 | ICU Medical | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | K262532 |
| Sep 11, 2026 | Ecomed Solutions, LLC | Ecomed Disposable Administration Sets | K254123 |
| Sep 10, 2026 | GC America, Inc. | Cerasmart Forte | K262202 |
| Sep 10, 2026 | OMRON Healthcare, Inc. | Upper Arm Blood pressure monitor (BP7155D) | K261929 |
| Sep 2, 2026 | Cardinalhealth | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | K261749 |
| Aug 25, 2026 | Sol-Millennium Medical, Inc. | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | K252184 |
| Aug 21, 2026 | Tempus AI, Inc. | Tempus ECG-PH | K253699 |
| Aug 11, 2026 | PolyConversions, Inc. | VR Personal Protective Level 4 Gown (VR Gowns) | K261115 |
- Oct 23, 2026LuxCreo, Inc.
LuxDesign
- Oct 21, 2026Sol-Millennium Medical, Inc.
Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- Sep 25, 2026SimBioSys, Inc.
TumorSight Risk
- Sep 25, 2026Tempus AI, Inc.
Tempus ECG-MR
- Sep 23, 2026Abbott Laboratories
Anti-HCV Next
- Sep 18, 2026ICU Medical
NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
- Sep 11, 2026Ecomed Solutions, LLC
Ecomed Disposable Administration Sets
- Sep 10, 2026GC America, Inc.
Cerasmart Forte
- Sep 10, 2026OMRON Healthcare, Inc.
Upper Arm Blood pressure monitor (BP7155D)
- Sep 2, 2026Cardinalhealth
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Aug 25, 2026Sol-Millennium Medical, Inc.
SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- Aug 21, 2026Tempus AI, Inc.
Tempus ECG-PH
- Aug 11, 2026PolyConversions, Inc.
VR Personal Protective Level 4 Gown (VR Gowns)
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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