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 |
|---|---|---|---|---|---|
| K994285 | Orthoralix 9200, Orthoralix 9200 Plus, Orthoralix 9200 Ceph, Orthoralix 9200 Plus Ceph | Dentsply Intl. | EHD | Class II | |
| K994254 | Interacoustics At235 Impedance Audiometer | International Distributors of Electronics for Medi | ETY | Class II | |
| K993280 | Prostec 125I Brachytherapy Seeds | Prostec, LLC | KXK | Class II | |
| K000675 | Manual Digital Blood Pressure Monitor, Model Hd-502 | Jawon Medical Co., Ltd. | DXN | Class II | |
| K000589 | Model 445Si-64E Quadrature Wrist Coil | Igc-Medical Advances, Inc. | MOS | Class II | |
| K000554 | Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for Pocket | Quantel Medical | IYO | Class II | |
| K000502 | Steam/eo Record Card, Model Ci 121 | Steritec Products Mfg. Co., Inc. | JOJ | Class II | |
| K000311 | Parapost Fiber White | Coltene /Whaledent AG | ELR | Class I | |
| K000016 | Barcomed 5Mp2 | Barco N.V. | LLZ | Class II | |
| K000014 | Barcomed 5Mp1h | Barco N.V. | LLZ | Class II | |
| K994365 | Dyonics Electroblade | Smith & Nephew, Inc. | GEI | Class II | |
| K994207 | Howmedica Osteonics Modular Rotating Hinge Knee | Howmedica Osteonics Corp | KRO | Class II | |
| K994157 | Datascope's 8Fr. Polymide 25Cc,34cc and 40Cc Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 | Datascope Corp. | DSP | Class II | |
| K993568 | Machida Flexible Neuro-Endoscope, Models Neu-4, Neu-4L | Machida Endoscope Co., Ltd. | GWG | Class II | |
| K993362 | Hylasine | Biomatrix, Inc. | EMX | Class I | |
| K993024 | Celsite Implantable Port with Valved Catheter | B. Braun of America, Inc. | LJT | Class II | |
| K992655 | Fertiloscopy Kit Fh 1.29/Fto 1.40 | Soprane S.A. | HEW | Class II | |
| K991413 | Codman Ethisorb Dura Patch | Johnson & Johnson Professionals, Inc. | GXQ | Class II | |
| K000628 | Wallace Oocyte Retrieval Set-16G, Model Meons1633; Wallace Oocyte Retrieval Set-17G, Model Meons1733 | Abbott Medical | MQE | Class II | |
| K000511 | Modification to Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spine Wands | ArthroCare Corporation | GEI | Class II | |
| K000498 | Coherent Laserlink Z-1000 Slit Lamp Laser Delivery Adapter | Lumenis Ltd | GEX | Class II | |
| K000490 | Cynosure Photogenica Vls-Star | Cynosure, LLC | GEX | Class II | |
| K000309 | Blastocyst Freeze Medium, Blastocyst Thaw Medium | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K000171 | Cbyon Surgical Operating System (Sos) | Cbyon, Inc. | HAW | Class II | |
| K000068 | Compumedics E-Series EEG System | Compumedics Neuro Science Pty, Ltd. | OLT | Class II | |
| K000054 | Foam Calcium Alginate Topical Wound Dressing with Collagen | Adri | KGN | Unclassified | |
| K994392 | Aequalis Shoulder Fracture System | TORNIER Inc. | KWS | Class II | |
| K994382 | Nonlinear Taper Lag Screw | Theken Surgical,Llc | HWC | Class II | |
| K994286 | Zmr Hip System-Porous Revision | Zimmer GmbH | LPH | Class II | |
| K993805 | Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves (Blue, Cherry Flavored) | Best Manufacturing Company | LZA | Class I | |
| K993259 | Inter-Op Durasul Acetabular Inserts/cocr Femoral Heads | Sulzer Orthopedics, Inc. | LPH | Class II | |
| K992856 | Magellan Humeral Intramedullary Nail | Orthomatrix, Inc. | HSB | Class II | |
| K992850 | Magellan Tibial Intramedullary Nail | Orthomatrix, Inc. | HSB | Class II | |
| K992821 | Synthetic Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | LYZ | Class I | |
| K000634 | Rod to Rod Cross Braces | Corin USA | KWQ | Class II | |
| K000575 | Global Advantage Extended Humeral Head | Depuy Orthopaedics Inc. | KWS | Class II | |
| K000476 | Modification to Cd Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K000453 | Modification to Cd Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K000450 | Modification to Synthes Uss | Synthes GmbH | MNI | Class II | |
| K000165 | Next Step Powder Free Latex Examination Gloves Contains 50 Mcgm or Less of Total Water Extractable Protein per Gram | Ansell Perry | LYY | Class I | |
| K000091 | Duracon Symmetric Metal-Backed Patellar Component | Howmedica Osteonics Corp | JWH | Class II | |
| K000058 | Brothers Powder-Free Vinyl Examination Gloves | Kaohsiung Brothers Products Corp. | LYZ | Class I | |
| K000009 | Spiral Radius Rodding System | United States Surgical, A Division of Tyco Healthc | KWQ | Class II | |
| K994270 | Instatrak 3000 System with Fluorotrak Module, Model It3000 | Visualization Technology, Inc. | LLZ | Class II | |
| K993946 | Pegasys Ultra | Philips North America LLC | LLZ | Class II | |
| K992762 | Brachyvision 6.0 | Varian Assoc., Inc. | MUJ | Class II | |
| K000656 | Embryon Gift Transfer Catheters/sets | Rocket Medical | MQF | Class II | |
| K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | IYO | Class II | |
| K000566 | Modofication to Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic Products Psa Calibrators | Ortho-Clinical Diagnostics, Inc. | LTJ | Class II | |
| K000544 | Boucher Degroot Head Positioning Glasses, Model 8080 | Labtician Ophthalmics, Inc. | HJX | Class I |