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 |
|---|---|---|---|---|---|
| K002574 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Model Radical, Lnop-Adt, Lnop-Pdt | Masimo Corporation | DQA | Class II | |
| K002158 | S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 Software | GE Healthcare | MHX | Class II | |
| K002026 | Capiox Arterial Filter | Terumo Medical Corp. | DTM | Class II | |
| K002016 | Philips Integris Allura | Philips North America LLC | OWB | Class II | |
| K002001 | Breeze Sleepgear with Dreamseal | Medtronic, Inc. | BZD | Class II | |
| K001987 | Explorer Gradient | Philips North America LLC | LNH | Class II | |
| K001796 | Gyroscan Intera (R7.5) | Philips North America LLC | LNH | Class II | |
| K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank | Augustine Medical, Inc. | DWJ | Class II | |
| K000743 | Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020 | Boston Scientific Corporation | DQO | Class II | |
| K994103 | Olympus Um-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract | OLYMPUS Corporation of the Americas | ITX | Class II | |
| K993675 | Peregrine Radiation Therapy Dose Calculation System | Nomos Corp. | MUJ | Class II | |
| K002609 | Tina-Quant Rheumatoid Factors II Test System | Roche Diagnostics GmbH | DHR | Class II | |
| K002602 | Obc-63 Mebreast Array Coil | Mri Devices Corp. | MOS | Class II | |
| K002380 | Infusor Sv, Infusor Lv, Baxter Pain Management System | Baxter Healthcare Corporation | FRN | Class II | |
| K002165 | Linezolid, 30Ug, Bbl Sensi-Disc | Dickinson, and Co. | JTN | Class II | |
| K002051 | Invidos | Scanditronix Medical AB | IYE | Class II | |
| K001907 | Camit Diabetes Management Software | Roche Diagnostics GmbH | CGA | Class II | |
| K002508 | Equipment Drapes | Medtronic, Inc. | KKX | Class II | |
| K002441 | Fenning Hip Stem | Depuy Orthopaedics Inc. | LZO | Class II | |
| K002432 | Strato X | Villa Sistemi Medicali S.p.A. | EHD | Class II | |
| K994041 | Tornier Bipolar Radial Head Prosthesis | TORNIER Inc. | KWI | Class II | |
| K994022 | Parallax Cranioset | Parallax Medical, Inc. | GXP | Class II | |
| K991864 | Rotaflow Centrifugal Pump System | Jostra Medizintechnik AG | KFM | Class II | |
| K002528 | Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer Option | Sienco, Inc. | JBP | Class II | |
| K002460 | Liquichek Lipids Control, Model 641, 642 | Bio-Rad | JJY | Class I | |
| K002453 | Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Models 34470, 34475, and 34479 | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K002422 | Varpr 3.5Mm 90 Suction Electrode for Use with Vapr System | Mitek Products | GEI | Class II | |
| K002402 | Vapr Tc Electrode for Use with Vapr II Electrosurgical System | Mitek Products | HRX | Class II | |
| K002379 | M2a 28Mm Ringloc Liner | Zimmer GmbH | KWA | Class III | |
| K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster Inc | DRF | Class II | |
| K002222 | Rd-2104 | J.F. Jelenko & Co., Inc. | EJT | Class II | |
| K002149 | Lineage Acetabular System | Wrightmedicaltechnologyinc | LPH | Class II | |
| K002109 | Oleeva Foam | Bio Med Sciences, Inc. | MDA | Class I | |
| K001898 | Vasotrax | Medwave, Inc. | DXN | Class II | |
| K001760 | Radiolucent Colles Fracture Kit | Zimmer GmbH | LXT | Class II | |
| K001712 | 3D Activetrac | The Saunders Group | ITH | Class II | |
| K001709 | Trochanteric Reattachment Device (Standard) and (Long), Model 501-066, 501-067 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | JDQ | Class II | |
| K001704 | Athos | Cosmos Medical Technology | GEX | Class II | |
| K001579 | Impulse Select | Airsep Corp. | NFB | Class II | |
| K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K000919 | 128 Channel EEG Headbox, Model Ex-Nw-128 | Excel Tech., Ltd. | GWQ | Class II | |
| K000700 | Sensidyne Oxygen Analyzer & Sensidyne Oxygen Monitor | Sensidyne, Inc. | CCL | Class II | |
| K000517 | Life Scope Ec, Model Bsm-1102 | Nihon Kohden America Inc | MHX | Class II | |
| K994283 | MRI- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems, B.V. | LNH | Class II | |
| K984570 | Minolta Pulsox-3/Minolta Pulsox-3I | In-X Corp. | DQA | Class II | |
| K002539 | Obc-096 Breast Array Coil | Mri Devices Corp. | MOS | Class II | |
| K002536 | Liquichek Blood Gas Plus Co-Oximeter Control, Models 637, 638, 639 (Radiometer) | Bio-Rad | JJS | Class I | |
| K002535 | Liquichec Blood Gas Pluse Control with Glucose, Model 511, 512, 513 | Bio-Rad | JJS | Class I | |
| K002533 | Tcd 100M, Pwd13 Transducer | Spencer Technologies | IYN | Class II | |
| K002404 | Micro-Max, Model 319 | Tek Marketing, Inc. | IXW | Class II |