510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K092562 | Microtargeting Star Drive System, Components | FHC, Inc. | HAW | Class II | |
| K092496 | Copran Zr/origin Yz | White Peaks Dental Systems GmbH & Co. KG | EIH | Class II | |
| K092189 | Pogo Screw | Fxdevices | HWC | Class II | |
| K092145 | 160Mlc Option | Siemens Medical Solutions USA, Inc. | IYE | Class II | |
| K092100 | Powder-Free, Yellow Vinyl Patient Examination Gloves | Tangshan Hongxing Plastic Products Co., Ltd. | LYZ | Class I | |
| K092067 | Abvs Workplace | Siemens AG Medical Solutions | LLZ | Class II | |
| K092018 | Omnipro Incline | IBA Dosimetry GmbH | IYE | Class II | |
| K092000 | Powder-Free, Yellow Vinyl Patient Examination Gloves | Shangdong Zibo Shanchuan Medical Instruments Co. | LYZ | Class I | |
| K091999 | Cyberknife Robotic Radiosurgery System | Accuray Incorporated | IYE | Class II | |
| K091898 | Blood Glucose Monitoring System, Model Fora G90/td-4234 | Taidoc Technology Corporation | NBW | Class II | |
| K091887 | LED Curing Light, Model Gt-1500 | Monitex Industrial Co., Ltd. | EBZ | Class II | |
| K091873 | Tryptik Ca Anterior Intersomatic Cervical Cage, Models Mos-Ca 12 05-S, Mos-Ca 12 O6-S | Spineart SA | ODP | Class II | |
| K091759 | Single Use Splinting Tube, Models St-Y0002-S, St-Y0002-H, St-Y0003-S and St-Y0003-H | Olympus Medical Systems Corp. | KNT | Class II | |
| K091559 | Marksmann Catheter | Chestnut Medical Technologies, Inc. | KRA | Class II | |
| K091534 | Lightlas Model 532 | Lightmed Corp. | HQF | Class II | |
| K091268 | Hospira Latex-Free Critical Care and Advanced Sensor Catheters | Abbott Medical | DQE | Class II | |
| K091122 | Diana Fusion Cage | Signus Medical, LLC | MAX | Class II | |
| K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | MQV | Class II | |
| K090810 | Thermo Scientific Cyto-Cal Count Tubes | Microgenics Corporation | GKZ | Class II | |
| K090773 | Cfi Ultrasound Probe Drape | Domico Med-Device, LLC | IYO | Class II | |
| K090742 | Digital Flat Panel X-Ray Detector, Model Ltx240aa01-a | Samsung Mobile Display Co., Ltd. | MQB | Class II | |
| K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 Lt | Gish Biomedical, Inc. | DTZ | Class II | |
| K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 Lt | Gish Biomedical, Inc. | DTZ | Class II | |
| K090429 | Nunc Ivf Centerwell and Icsi Dishes | Thermo Fisher Scientific (Nalge Nunc Intl) | MQK | Class II | |
| K090216 | Collagen Dental Membrane IV | Collagen Matrix, Inc | NPL | Class II | |
| K082118 | Xpert Hemosil Factor II & Factor V Assay | Cepheid | NPQ | Class II | |
| K092716 | Esophageal Stethoscope | Truer Medical, Inc. | BZT | Class II | |
| K091731 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | FLE | Class II | |
| K091608 | Cobalt Mv Bone Cement | Biomet Manufacturing Corp | LOD | Class II | |
| K092594 | Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-Ox, 09-2703-Ox, 09-2705-Ox | Ace Surgical Supply Co., Inc. | DZE | Class II | |
| K092506 | Easyra Glu-H Reagent, Model 10200 | Medica Corp. | CFR | Class II | |
| K092416 | Powdered Vinyl Patient Examination Gloves | Shijiazhuang Elegance Plastic Product | LYZ | Class I | |
| K092347 | Pro-Picc CT | Medcomp | LJS | Class II | |
| K092319 | Star Vps, Model 80014-01, First Quater, Model 90649, First Half, Model 89387 | Danville Materials, Inc. | ELW | Class II | |
| K092200 | Powder Free Nitrile Examination Gloves, Orange (Orange Scented), White (Vanilla Scented) | Gx Corporation Sdn Bhd | LZA | Class I | |
| K091953 | Pro-Picc | Medcomp | LJS | Class II | |
| K091202 | Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,model 1000-01 Tab Varying Diameters, | Medshape, Inc. | HWC | Class II | |
| K083817 | M. Dior Brand | Suzhou Colour-Way Enterprise Development Co., Ltd. | HIS | Class II | |
| K092698 | Quickvue Influenza A+b Test | Ortho-Clinical Diagnostics, Inc. | PSZ | Class II | |
| K092577 | Ethicon Endo-Surgery Linear Cutter 55Mm (Ntlc55),selectable Cartridge 55 / 75Mm (Sr55/75) ,Linear Cutter 75Mm (Ntlc75) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | Beere Precision Medical Instruments, Kmedic, Telef | GAT | Class II | |
| K092304 | Esteem Ortho Polyisoprene Powder-Free Surgical Gloves | Medtronic, Inc. | KGO | Class I | |
| K092134 | Stat Pacs Picture Archiving & Communication System (Pacs) | StatRad, LLC | LLZ | Class II | |
| K092019 | Model 1014 Pc Electrometer | Sun Nuclear Corporation | IYE | Class II | |
| K091350 | Estech Hawkeye Introducer Systems | Endoscopic Technologies, Inc. D/B/A Estech | GCJ | Class II | |
| K091117 | Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model Iaslbka | Isoaid, L.L.C. | KXK | Class II | |
| K083715 | Beltbeat Wf-400 | Bonus Communicaciones SRL | DPS | Class II | |
| K081996 | Flexstent Biliary Self Expanding Stent System | Flexible Stenting Solutions, Inc. | FGE | Class II | |
| K092128 | Modification to: Pss System | Spinal USA | MNI | Class II | |
| K091968 | Karl Storz LED Nova 100 Cold Light Fountain, Models 2016020, 20161020C | Karl Storz Endoscopy-America, Inc. | FCW | Class II |