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 |
|---|---|---|---|---|---|
| K081217 | Hy-Tec Specific and Total Ige Eia System | Hycor Biomedical | DHB | Class II | |
| K080257 | Microfrance Laparoscopic Manual Surgical Instruments | Medtronic Xomed, Inc. | GCJ | Class II | |
| K080159 | Kronus Tsh Receptor Autoantibody (Trab) Elisa Assay Kit | Kronus Market Development Associates, Inc. | JZO | Class II | |
| K073684 | Sheffield Pharmaceuticals (Sterile) Lubrigel | Sheffield Industries, Div. of Faria, Ltd. | KMJ | Class I | |
| K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models Spk0021, Spk0121, Spk0221, Spk0321 | Tecres SpA | JWH | Class II | |
| K062273 | Spacer-G Temporary Hip Prosthesis | Tecres SpA | KWL | Class II | |
| K081046 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | DYB | Class II | |
| K080839 | Echelon Gray Cartridge, Model Erc45m | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K080767 | Conquest Spinal System | Life Spine | MNI | Class II | |
| K080699 | Novel Spinal Spacer System | Alphatec Spine, Inc. | MQP | Class II | |
| K080598 | Mini Drive-Lock Dental Implant System Prosthetics | Intra-Lock International | NHA | Class II | |
| K080479 | Dental Ceramic | Dmg USA, Inc. | EIH | Class II | |
| K073551 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | KCT | Class II | |
| K072904 | Sonoca 180/195 Wound Care System | Soering GmbH | LFL | Unclassified | |
| K070412 | Elexoma Medic | Redplane AG | QJQ | Class II | |
| K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron BV | MUJ | Class II | |
| K081040 | Powdered Latex Examination Gloves, Small, Medium, Large, X-Large | Pt.Shamrock Manufacturing Corp. | LYY | Class I | |
| K081009 | Neutrophase | Novabay Pharmaceuticals, Inc | KMF | Class I | |
| K080946 | Conmed Axcess Papillotome Models Ax4535, Ax4535fx | Conmed Endoscopic Technologies, Inc. | KNS | Class II | |
| K080403 | Xtjf Type Q160vf1 | Olympus Medical Systems Corp. | FDT | Class II | |
| K080620 | Modification to 3M Tegaderm Chg Dressing | 3M Company-3M Health Care | FRO | Unclassified | |
| K072600 | Intracytoplasmic Sperm and Spermatid Injection, Holding, Zone Drilling, Partial Zone Dissection and Denuding Pipettes | Sunlight Medical, Inc. | MQH | Class II | |
| K071889 | Datex-Ohmeda S/5 Critical Care Monitor with L-Icu05 and L-Icu05a Software | GE Healthcare | DSI | Class II | |
| K081142 | Auto-Band Ligator | Scandimed International | MND | Class II | |
| K081110 | Siui Cts-900 Digital Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | IYO | Class II | |
| K080994 | Amplatzer Torqvue Exchange System | Abbott Medical | DQY | Class II | |
| K080954 | T34l Syringe Driver | Caesarea Medical Electronics, Ltd. | FRN | Class II | |
| K080713 | Reactive Dental Implant System | Implant Direct, LLC | DZE | Class II | |
| K080578 | Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (Pbnp) Flex Reagent Cartridge (K6423a), Dimension Vista | Siemens Healthcare Diagnostics Inc. | NBC | Class II | |
| K080515 | Fmri Hardware System | NordicNeuroLab AS | LNH | Class II | |
| K080439 | Sandman Info without Humidifier/ Sandman Auto without Humidifier, Model M-114801-114802-US; Sandman Info with Intergrate | Mallinckrodt Developpement France | BZD | Class II | |
| K080168 | Shuntcheck - Csf Shunt Flow Detector | Neuro Diagnostic Devices | JXG | Class II | |
| K080029 | Mako Surgical Corp. Patellofemoral Knee Implant System | Mako Surgical Corp. | KRR | Class II | |
| K073070 | Dio Biotite-H Implant System | Dio Department Dsi, Inc. | DZE | Class II | |
| K072300 | Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | |
| K072276 | Subdermal Needle Electrodes | Xian Friendship Electronics Co., Ltd. | GXZ | Class II | |
| K072258 | Bi-Rads Companion | Almen Laboratories, Inc. | LLZ | Class II | |
| K081253 | Zirdent Cad/cam Blocks | C5 Medical Werks, Inc. | EIH | Class II | |
| K081090 | Profemur Lx 5/8 Coated Hip Stem | Wrightmedicaltechnologyinc | KWA | Class III | |
| K080818 | Hemcon Bandage, Hemcon Bandage OTC, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | QSY | Unclassified | |
| K080762 | Ib Neuro, Version 1.0 | Imaging Biometrics, LLC | LNH | Class II | |
| K080694 | Osteomed Modular Locking Fixation System | Osteomed | JEY | Class II | |
| K080662 | Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator | Genzyme Corporation | NDY | Class II | |
| K080587 | Ez Manager Max Diabetes Management Software | Animas Corp. | MRZ | Class II | |
| K080582 | Medicatech, Model Ddr Mak-800, Ddt Mak-1000 Fs, Ddr Mak-1100 Fa | Medicatech USA | KPR | Class II | |
| K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc | FTM | Class II | |
| K080411 | Plateau Spacer System | Life Spine | MAX | Class II | |
| K080374 | Biosyag Medical System | Bios S.r.l. | GEX | Class II | |
| K080227 | Accu-Chek 360 Diabetes Management System | Roche Diagnostics GmbH | MRZ | Class II | |
| K073562 | Modification to Viper Spine System | DePuy Spine, Inc. | NKB | Class II |