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 |
|---|---|---|---|---|---|
| K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252 (220 V), 00 002 318 (110 V); | Moeller Medical GmbH & Co. KG | QPB | Class II | |
| K062381 | Capiox Rx Oxygenator with or without Reservoir | Terumo Cardiovascular Systems Corporation | DTZ | Class II | |
| K062293 | Microscan Microstrep Plus Panel Chloramphenicol (1 to 32 Mcg/ml) | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K062169 | Applied Laparoscopic Disposable Monopolar Scissors | Applied Medical Resources Corp | HET | Class II | |
| K062140 | Surgifrost Xl Cryosurgical Device, Model 60Sfxl; Cryosurgical Console, Model 65Cs1 | Medtronic CryoCath LP | OCL | Class II | |
| K062137 | Modification to Philips Avalon Fetal Monitors Fm20 and Fm30 | Philips Medizin Systeme Boeblingen GmbH | HGM | Class II | |
| K061845 | Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K061733 | Angiodynamics Soft-Vu and Mariner Hydrophilic Coated Angiographic Catheter | Boston Scientific Corporation | DQO | Class II | |
| K061689 | Aquatine Ec Endodontic Cleanser | Puricore, Inc. | KJJ | Unclassified | |
| K061666 | Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex | Mauna Kea Technologies | GCJ | Class II | |
| K061551 | Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Ug or Less) | Medipure Corporation (M) Sdn. Bhd. | LYY | Class I | |
| K061325 | Bodygaurd Pain Manager Infusion System | Caesarea Medical Electronics, Ltd. | FRN | Class II | |
| K061289 | Arrow Pressure Injectable Picc | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | Class II | |
| K061194 | Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558 | Abbott Medical | MEG | Class II | |
| K060958 | Straumann Narrow Neck Implants | Straumann USA, LLC | DZE | Class II | |
| K060854 | Abx Pentra 400: Lipoproteins | Horiba Abx | JIT | Class II | |
| K060072 | Monoblock Press-Fit Hip Stem | Omni Life Science, Inc. | LPH | Class II | |
| K062298 | Apollo Gamma Camera System | Philips North America LLC | KPS | Class II | |
| K062276 | Microscan Microstrep Plus Panel | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K062245 | Hardy Disk Ast Tigecycline 15 Ug, Modelz936 | Hardy Diagnostics | JTN | Class II | |
| K062179 | Microscan Dried Gram-Positive Mic/combo Panels with Erythromycin (0.25 - 16Ug/ml) | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K062173 | Modification to Bone Graft Syringe | Wrightmedicaltechnologyinc | FMF | Class II | |
| K062145 | Modified Acumen Lead Delivery Sheath, Models Lds-10-57, Lds-10-57-90, Lds-10-64 and Lds-10-64-90 | Acumen Medical, Inc. | DYB | Class II | |
| K061872 | Microscan Microstrep Plus Panel | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K061674 | Rta 5 & Rta Model E Retinal Thickness Analyzer | Talia Technology, Ltd. | HLI | Class II | |
| K061529 | Procera Zirconia Abutment for Camlog Implant System | Nobel Biocare AB | NHA | Class II | |
| K061246 | Endoscopic Spine System | Arthro Kinetics, Inc. | HRX | Class II | |
| K060773 | Online Tdm Procainamide | Roche Diagnostics GmbH | LAR | Class II | |
| K062170 | Bioknotless and Lupine Plus Anchors | DePuy Mitek, Inc. | JDR | Class II | |
| K062134 | Vigileo Arterial Pressure Cardiac Output/oximetry Monitor | Edwards Lifesciences LLC | DXG | Class II | |
| K061959 | Mytech / Happy Life / Maxiaids Arm Blood Pressure Monitor, Hpl-301, Hpl-302, Hpl-310, 180310 | Mytech Technology Co., Ltd. | DXN | Class II | |
| K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | JOW | Class II | |
| K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 | MAQUET CARDIOPULMONARY GmbH | DTZ | Class II | |
| K061600 | Arx Spinal System | Life Spine | MNI | Class II | |
| K061434 | Trident Large Diameter Hip System | Howmedica Osteonics Corp | LPH | Class II | |
| K061369 | Tandem Heart Escort (t.h.e.) Controller, Model 5140-8500 | Cardiacassist, Inc. | DWA | Class II | |
| K060911 | Cg-6108 Arrhythmia ECG Event Recorder | Card Guard Scientific Survival, Ltd. | DXH | Class II | |
| K062389 | Z-Block, Models 20/19, 40/19, 55/19 | Foundation Milling Centre | EIH | Class II | |
| K062328 | Vitreaaccess, Version 1.0 | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K062236 | Dimension Vista Cyclosporine (Csa) Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | MKW | Class II | |
| K062191 | Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models Kc515 and Kc516 | Siemens Healthcare Diagnostics Inc. | DIF | Class I | |
| K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | HAW | Class II | |
| K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Siemens Healthcare Diagnostics Inc. | JHS | Class II | |
| K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | IWB | Class II | |
| K061920 | Novapacs, Novaview, Novacardio, Novaqc and Novaer | Novarad Corp. | LLZ | Class II | |
| K061838 | Dimension Vista Chemistry 1 Calibrator, Model Kc110 | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K061798 | Biopro Memory Staple | Biopro, Inc. | JDR | Class II | |
| K061541 | Ksea Bipolar Electrotome | Ksea | FAS | Class II | |
| K061480 | Attain 6227Def Deflectable Catheter Delivery System | Medtronic Ireland | DQY | Class II | |
| K061478 | Procera Titanium Abutment for Astratech and Camlog Implant Systems | Nobel Biocare AB | NHA | Class II |