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Data / FDA device clearances / Illinois

FDA device clearances in Illinois: 225 since Nov 2024

The full list. FDA device clearances for applicants in Illinois: 225 rows for $11.25, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 8 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/illinois, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 29, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 225 device decisions for applicants in Illinois from November 12, 2024 to October 29, 2026: 126 510(k) clearances and De Novo grants and 99 PMA approvals and supplements, for 55 applicants. The newest, P230040/S030 on October 29, 2026, is Cordella Pulmonary Artery Sensor System from Endotronix, Inc..

The request: Every new FDA device clearance or approval for a company in Illinois, with its address, the device and the product code. $10 of credit on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

  • 225Decisions
  • 126510(k) and De Novo
  • 99PMA
  • October 29, 2026Latest decision

Newest decisions

The newest 100 of 225, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 29, 2026P230040/S030Cordella Pulmonary Artery Sensor SystemEndotronix, Inc.IllinoisApprovedPMA 180-day supplementMOMaccessdata.fda.gov
October 23, 2026P210011/S006xT CDxTempus AI, Inc.Illinois30-day notice acceptedPMA 30-day noticePQPaccessdata.fda.gov
October 23, 2026K260421LuxDesignLuxCreo, Inc.IllinoisSubstantially Equivalent510(k) traditionalPNNaccessdata.fda.gov
October 21, 2026K260857Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc.IllinoisSubstantially Equivalent510(k) specialJKAaccessdata.fda.gov
October 20, 2026P230040/S035Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
October 20, 2026DEN260027Elecsys HBsAg II quant II RxDxRoche DiagnosticsIllinoisUnknownDe NovoSJMaccessdata.fda.gov
October 16, 2026P230040/S031Cordelia™ Pulmonary Artery Pressure Sensor System (CorPASS)Endotronix, Inc.IllinoisApprovedPMA real-time process supplementMOMaccessdata.fda.gov
October 14, 2026P230040/S034Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
September 25, 2026P230040/S033Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
September 25, 2026K260023TumorSight RiskSimBioSys, Inc.IllinoisSubstantially Equivalent510(k) traditionalSHWaccessdata.fda.gov
September 25, 2026K254297Tempus ECG-MRTempus AI, Inc.IllinoisSubstantially Equivalent510(k) traditionalSBQaccessdata.fda.gov
September 23, 2026K262156Anti-HCV NextAbbott LaboratoriesIllinoisSubstantially Equivalent510(k) traditionalMZOaccessdata.fda.gov
September 18, 2026K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalIllinoisSubstantially Equivalent510(k) traditionalLGZaccessdata.fda.gov
September 11, 2026K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCIllinoisSubstantially Equivalent510(k) abbreviatedFPAaccessdata.fda.gov
September 10, 2026K262202Cerasmart ForteGC America, Inc.IllinoisSubstantially Equivalent510(k) traditionalEBFaccessdata.fda.gov
September 10, 2026K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.IllinoisSubstantially Equivalent510(k) specialDXNaccessdata.fda.gov
September 2, 2026P230003/S019Alinity m HR HPVAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeMAQaccessdata.fda.gov
September 2, 2026P210011/S002xT CDxTempus AI, Inc.IllinoisApprovedPMA 180-day supplementPQPaccessdata.fda.gov
September 2, 2026K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthIllinoisSubstantially Equivalent510(k) traditionalLZAaccessdata.fda.gov
August 25, 2026K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.IllinoisSubstantially Equivalent510(k) traditionalFMFaccessdata.fda.gov
August 21, 2026K253699Tempus ECG-PHTempus AI, Inc.IllinoisSubstantially Equivalent510(k) traditionalSATaccessdata.fda.gov
August 13, 2026P230040/S032Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
August 11, 2026K261115VR® Personal Protective Level 4 Gown (VR Gowns)PolyConversions, Inc.IllinoisSubstantially Equivalent510(k) traditionalQPCaccessdata.fda.gov
August 7, 2026P210036/S009PerClot® Polysaccharide Hemostatic SystemBaxter Healthcare CorporationIllinoisApprovedPMA 135-day supplementLMGaccessdata.fda.gov
August 7, 2026P210036/S008PerClot® Polysaccharide Hemostatic SystemBaxter Healthcare CorporationIllinoisApprovedPMA 135-day supplementLMGaccessdata.fda.gov
July 29, 2026K253526NAMIC Dilator and SheathMedline Industries, LPIllinoisSubstantially Equivalent510(k) traditionalDYBaccessdata.fda.gov
July 28, 2026K261430TruLift Expandable SystemLife Spine, Inc.IllinoisSubstantially Equivalent510(k) traditionalMAXaccessdata.fda.gov
July 23, 2026P230003/S015Alinity m HR HPVAbbott Molecular, Inc.IllinoisApprovedPMA 180-day supplementMAQaccessdata.fda.gov
July 15, 2026P830063/S032PRISMAFLEX TPE2000 SETVantive US Healthcare, LLCIllinois30-day notice acceptedPMA 30-day noticeMDPaccessdata.fda.gov
July 14, 2026K253662LIXI (LXOSFM1)Luwi, LLCIllinoisSubstantially Equivalent510(k) traditionalMSCaccessdata.fda.gov
July 6, 2026K253317Cytrans™ ElashieldGC America, Inc.IllinoisSubstantially Equivalent510(k) traditionalLYCaccessdata.fda.gov
June 22, 2026P230003/S018Alinity m HR HPVAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeMAQaccessdata.fda.gov
June 22, 2026K254287Medline Reusable Blood Pressure CuffMedline Industries, LPIllinoisSubstantially Equivalent510(k) traditionalDXQaccessdata.fda.gov
June 18, 2026K261246SRGC-06GC America, Inc.IllinoisSubstantially Equivalent510(k) traditionalEBFaccessdata.fda.gov
June 18, 2026K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.IllinoisSubstantially Equivalent510(k) traditionalFMFaccessdata.fda.gov
June 11, 2026K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.IllinoisSubstantially Equivalent510(k) traditionalIORaccessdata.fda.gov
June 8, 2026P230003/S014Alinity m HR HPV AssayAbbott Molecular, Inc.IllinoisApprovedPMA real-time process supplementMAQaccessdata.fda.gov
June 8, 2026P210036/S007PerClot® Polysaccharide Hemostatic SystemBaxter Healthcare CorporationIllinoisApprovedPMA 180-day supplementLMGaccessdata.fda.gov
June 5, 2026K251684Alma TED+ SystemAlma Lasers, Inc.IllinoisSubstantially Equivalent510(k) traditionalOAPaccessdata.fda.gov
June 2, 2026K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.IllinoisSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
May 28, 2026P230003/S017Alinity m HR HPVAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeMAQaccessdata.fda.gov
May 28, 2026P210011/S004xT CDxTempus AI, Inc.IllinoisApprovedPMA 180-day supplementPQPaccessdata.fda.gov
May 28, 2026P170041/S009Abbott RealTime IDH1Abbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeOWDaccessdata.fda.gov
May 28, 2026P170005/S006Abbott RealTime IDH2Abbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeOWDaccessdata.fda.gov
May 27, 2026K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.IllinoisSubstantially Equivalent510(k) traditionalGKZaccessdata.fda.gov
May 22, 2026DEN250057PCWP Analysis SoftwareCardiosense, Inc.IllinoisUnknownDe NovoSIFaccessdata.fda.gov
May 19, 2026P230003/S016Alinity m HR HPVAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeMAQaccessdata.fda.gov
May 19, 2026K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex CorporationIllinoisSubstantially Equivalent510(k) traditionalPCHaccessdata.fda.gov
May 18, 2026K254109G-CEM UNIVERSALGC America, Inc.IllinoisSubstantially Equivalent510(k) traditionalEMAaccessdata.fda.gov
May 18, 2026K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedIllinoisSubstantially Equivalent510(k) traditionalEZDaccessdata.fda.gov
May 15, 2026P230003/S013Alinity m HR HPVAbbott Molecular, Inc.IllinoisApprovedPMA real-time process supplementMAQaccessdata.fda.gov
May 12, 2026K260837VersaLift Expandable SystemLife Spine, Inc.IllinoisSubstantially Equivalent510(k) traditionalMAXaccessdata.fda.gov
May 11, 2026P120008/S032ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90)Abbott LaboratoriesIllinois30-day notice acceptedPMA 30-day noticeLOKaccessdata.fda.gov
April 28, 2026K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLCIllinoisSubstantially Equivalent510(k) abbreviatedFYAaccessdata.fda.gov
April 28, 2026K252424Anti-HCV NextAbbott LaboratoriesIllinoisSubstantially Equivalent510(k) traditionalMZOaccessdata.fda.gov
April 21, 2026K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.IllinoisSubstantially Equivalent510(k) traditionalFDSaccessdata.fda.gov
April 16, 2026K254274ARx® SAI Implant SystemLife Spine, Inc.IllinoisSubstantially Equivalent510(k) traditionalNKBaccessdata.fda.gov
April 16, 2026K253260ORIO-3D Cage SystemSpineCraftIllinoisSubstantially Equivalent510(k) traditionalODPaccessdata.fda.gov
April 10, 2026K253510Freestyle Mini Hands-freeMedela, LLCIllinoisSubstantially Equivalent510(k) traditionalHGXaccessdata.fda.gov
April 7, 2026K260048Elecsys Anti-HAV IgMRoche DiagnosticsIllinoisSubstantially Equivalent510(k) traditionalLOLaccessdata.fda.gov
April 2, 2026K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc.IllinoisSubstantially Equivalent510(k) traditionalPHCaccessdata.fda.gov
April 1, 2026K253586RM Electrode (RMH 25-01)Retmap, Inc.IllinoisSubstantially Equivalent510(k) traditionalHLZaccessdata.fda.gov
March 25, 2026K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT /...Medline Industries, LPIllinoisSubstantially Equivalent510(k) traditionalBZEaccessdata.fda.gov
March 20, 2026P170041/S008Abbott RealTime IDH1Abbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeOWDaccessdata.fda.gov
March 20, 2026P170005/S005Abbott RealTime IDH2Abbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeOWDaccessdata.fda.gov
March 13, 2026P830063/S030Prismaflex TPE2000 SetVantive US Healthcare, LLCIllinoisApprovedPMA real-time process supplementMDPaccessdata.fda.gov
March 12, 2026P230003/S011Alinity m HR HPVAbbott Molecular, Inc.IllinoisApprovedPMA real-time process supplementMAQaccessdata.fda.gov
March 4, 2026K260015ANTERIS Thoracolumbar Plate SystemSpineCraftIllinoisSubstantially Equivalent510(k) traditionalKWQaccessdata.fda.gov
March 2, 2026P230040/S029Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
February 26, 2026K253021ANNE MaternalSibel Health, Inc.IllinoisSubstantially Equivalent510(k) traditionalHGMaccessdata.fda.gov
February 25, 2026K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)IllinoisSubstantially Equivalent510(k) specialFQHaccessdata.fda.gov
February 25, 2026K251687Konig Bell Circumcision ClampMedline Industries, LPIllinoisSubstantially Equivalent510(k) traditionalHFXaccessdata.fda.gov
February 24, 2026P230040/S028Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
February 24, 2026P230003/S012Alinity m HR HPVAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeMAQaccessdata.fda.gov
February 23, 2026P910007/S068ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92)Abbott LaboratoriesIllinois30-day notice acceptedPMA 30-day noticeMTFaccessdata.fda.gov
February 20, 2026K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)BdIllinoisSubstantially Equivalent510(k) traditionalFQHaccessdata.fda.gov
February 18, 2026P150041/S008Vysis CLL FISH Probe KitAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticePNKaccessdata.fda.gov
February 18, 2026P110012/S023Vysis ALK Break Apart FISH Probe KitAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeOWEaccessdata.fda.gov
February 18, 2026P030052/S030UroVysion Bladder Cancer KitAbbott MolecularIllinois30-day notice acceptedPMA 30-day noticeaccessdata.fda.gov
February 17, 2026P230040/S027Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
February 13, 2026P230040/S026Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.IllinoisApprovedPMA special supplementMOMaccessdata.fda.gov
February 13, 2026K253149Motion InBra (YM-8801) wearable breast pumpMedela, LLCIllinoisSubstantially Equivalent510(k) traditionalHGXaccessdata.fda.gov
February 12, 2026P980007/S056ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93)Abbott LaboratoriesIllinois30-day notice acceptedPMA 30-day noticeMTGaccessdata.fda.gov
February 12, 2026P910007/S067ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92)Abbott LaboratoriesIllinois30-day notice acceptedPMA 30-day noticeMTFaccessdata.fda.gov
February 12, 2026P120008/S031ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90)Abbott LaboratoriesIllinois30-day notice acceptedPMA 30-day noticeLOKaccessdata.fda.gov
February 10, 2026K254016MI View&GOSiemens Medical Solutions USA, Inc.IllinoisSubstantially Equivalent510(k) specialQIHaccessdata.fda.gov
February 6, 2026K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLCIllinoisSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
January 23, 2026K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.IllinoisSubstantially Equivalent510(k) traditionalMAXaccessdata.fda.gov
January 22, 2026K253498Pump In Style® Pro+Medela, LLCIllinoisSubstantially Equivalent510(k) specialHGXaccessdata.fda.gov
January 15, 2026DEN250009VitaSmart Hypothermic Oxygenated Perfusion SystemBridge TO Life, Ltd.IllinoisUnknownDe NovoSGYaccessdata.fda.gov
January 14, 2026K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthIllinoisSubstantially Equivalent510(k) traditionalLZCaccessdata.fda.gov
January 9, 2026P230040/S025Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.Illinois30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
January 8, 2026K253639ViewGE HealthcareIllinoisSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
January 6, 2026P230003/S010Alinity m HR HPVAbbott Molecular, Inc.Illinois30-day notice acceptedPMA 30-day noticeMAQaccessdata.fda.gov
December 23, 2025P830063/S031Gambro Prismaflex TPE 2000 SetVantive US Healthcare, LLCIllinois30-day notice acceptedPMA 30-day noticeMDPaccessdata.fda.gov
December 19, 2025P230040/S015CorPASS SystemEndotronix, Inc.IllinoisApprovedPMA 180-day supplementMOMaccessdata.fda.gov
December 18, 2025P030039/S032Coseal Applicator TipsBaxter Bio ScienceIllinois30-day notice acceptedPMA 30-day noticeNBEaccessdata.fda.gov
December 16, 2025K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.IllinoisSubstantially Equivalent510(k) traditionalQPCaccessdata.fda.gov
December 16, 2025K252204prolaio eVO2peak Module (Version 1.0)Prolaio, Inc.IllinoisSubstantially Equivalent510(k) traditionalPPWaccessdata.fda.gov
December 16, 2025K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare CorporationIllinoisSubstantially Equivalent510(k) traditionalDXQaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Abbott Molecular, Inc.34September 2, 2026
Endotronix, Inc.30October 29, 2026
Abbott Laboratories16September 23, 2026
Baxter Healthcare Corporation13August 7, 2026
Medline Industries, LP11July 29, 2026
Life Spine, Inc.9July 28, 2026
Tempus AI, Inc.8October 23, 2026
GC America, Inc.7September 10, 2026
Sol-Millennium Medical, Inc.5October 21, 2026
Vantive US Healthcare, LLC5July 15, 2026
Icu Medical, Inc.5April 2, 2026
Cardinalhealth4September 2, 2026
Alma Lasers, Inc.4June 5, 2026
Sysmex America, Inc.4May 27, 2026
Abbott Molecular4February 18, 2026
LuxCreo, Inc.3October 23, 2026
Luminex Corporation3May 19, 2026
EvoEndo, Inc.3April 21, 2026
Medela, LLC3April 10, 2026
Siemens Medical Solutions USA, Inc.3February 10, 2026

By panel

PanelDecisionsLatest
Cardiovascular48October 29, 2026
Microbiology40September 23, 2026
General Hospital21September 18, 2026
General, Plastic Surgery17August 11, 2026
Gastroenterology, Urology16July 15, 2026
Pathology12October 23, 2026
Dental12October 23, 2026
Orthopedic12July 28, 2026
Immunology8May 11, 2026
Radiology8February 10, 2026
Obstetrics/Gynecology6July 14, 2026
Medical Genetics5May 28, 2026
Hematology4May 27, 2026
Anesthesiology4March 25, 2026
Neurology3June 2, 2026
Clinical Chemistry2October 21, 2026
Physical Medicine2June 11, 2026
Ophthalmic2April 1, 2026
Unknown1October 20, 2026
Ear, Nose, Throat1August 11, 2025
Clinical Toxicology1July 9, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional108October 23, 2026
PMA 30-day notice69October 23, 2026
PMA real-time process supplement14October 16, 2026
510(k) special13October 21, 2026
PMA 180-day supplement9October 29, 2026
PMA 135-day supplement4August 7, 2026
De Novo3October 20, 2026
510(k) abbreviated2September 11, 2026
PMA special supplement1February 13, 2026
PMA panel track supplement1September 10, 2025
PMA original approval1August 15, 2025

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. 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.