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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K151215 | Mercury Spinal System | Spinal Elements, Inc | NKB | Class II | |
| K151115 | MR Core Software | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K150949 | FibroScan | Echosens | IYO | Class II | |
| K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | NDC | Class II | |
| K150570 | ANAX OCT Spinal System | CG MedTech Co., Ltd. | NKG | Class II | |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 | Shenzhen Creative Industry Co., Ltd | DQA | Class II | |
| K143432 | Cardio-TriTest | Cardio-Phoenix, Inc. | DPS | Class II | |
| K143387 | GE333 Blood Glucose Monitoring System | Bionime Coporation | NBW | Class II | |
| K143204 | AOS Clavicle Intramedullary Device | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | |
| K142159 | Disposable Pre-Gelled Surface Electrode | Rochester Electro Medical, Inc. | GXY | Class II | |
| K141637 | Spb Skin Emulsion | Biotd S.A. | FRO | Unclassified | |
| K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | Nemera | MEG | Class II | |
| K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | FBK | Class II | |
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology, Ltd. | DZI | Class II | |
| K150042 | PleuraFlow System | Clearflow, Inc | OTK | Class II | |
| K143524 | Fiber Disks and Blocks (TRINIA) | Bicon, LLC | EBF | Class II | |
| K142794 | Everyway Facial MENS | Everyway Medical Instruments Co., Ltd. | NFO | Class II | |
| K141188 | Microdent Genius Implant System | Implant Microdent | DZE | Class II | |
| K151132 | Probeat-V | Hitachi, Ltd., Health Care Company | LHN | Class II | |
| K150617 | cobas HSV 1 and 2 Test | Roche Molecular Systems Inc | OQO | Class II | |
| K150549 | Reactor(TM) Trocar and Sleeve | Sharp Medical Prducts, LLC | GCJ | Class II | |
| K143397 | ICIS View | AGFA Healthcare Corp. | LLZ | Class II | |
| K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) | Roosin Medical Devices Co., Ltd. | FRO | Unclassified | |
| K143086 | VX120 Ophthalmic Diagnostic Device | Luneau SAS | HKX | Class II | |
| K141531 | Power-Trialysis Slim-Cath Short-Term Dialysis Catheter | C.R. Bard Inc | NIE | Class II | |
| K142692 | Occlusion Balloon Catheter | Embolx Inc. | MJN | Class II | |
| K150526 | Optilite IgG4 Kit | The Binding Site Group Ltd. | CFN | Class II | |
| K151163 | Signia Loading Unit, Tri-Staple 2.0 Cartridge | Medtronic, Inc. | GDW | Class II | |
| K150890 | Exactech Optetrak Logic CC | Exactech, Inc. | JWH | Class II | |
| K150887 | Para-Fix C&S Medium | Medical Chemical Corporation | JSM | Class I | |
| K150885 | MAGEC 2 Spinal Bracing and Distraction System | Ellipse Technologies, Incorporated | PGN | Class II | |
| K150778 | Various Brands of Ultraviolet Lamps | Cosmedico Light, Inc. | LEJ | Class II | |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector | Boston Scientific Corporation | PIF | Class II | |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System | Aesculap Inc | JWH | Class II | |
| K150271 | Prime Adaptive Ultrasonic Scalpel System | Endoprime, Inc. | LFL | Unclassified | |
| K143496 | Piccolo Composite Plate System | CarboFix Orthopedics Inc. | HRS | Class II | |
| K143430 | SmartTENS | Easy Med Instrument Co., Ltd. | NUH | Class II | |
| K143321 | ITST Intertrochanteric/Subtrochanteric Fixation System | Zimmer GmbH | HSB | Class II | |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Medtronic, Inc. | LZH | Class II | |
| K143028 | Azure Anterior Cervical Plate System | Orthofix SRL | KWQ | Class II | |
| K142768 | Instru-Safe Instrument Protection System | Summit Medical, LLC | KCT | Class II | |
| K142478 | opti-Toe | Graham Medical Technologies, LLC (D.B.A.Gramedica) | HTY | Class II | |
| K142417 | SP-1PSpecular Microscope | Topcon Corp. | NQE | Class II | |
| K141907 | Stat Profile Prime Ccs Analyzer System, Stat Profile Prime Auto Qc Cartridge Ccs, Stat Profile Prime Ampuled Control Abg/ccs, Stat Profile Prime Calibrtor Cartridge Ccs/ccs Comp, Nova Linearity Standard Set a | Nova Biomedical Corporation | CHL | Class II | |
| K150824 | TD-Wand | Tdm Surgitech, Inc. | GEI | Class II | |
| K150802 | Heavy Double Flexible Tipped Wire Guide | Cook Incorporated | DQX | Class II | |
| K150513 | Imed Technology Intravascular Administration Set, Imed Technology Extension Set | Imed Technology, Inc. | FPA | Class II | |
| K150130 | Ascendant TM Cervical Spacer System | Exactech, Inc. | ODP | Class II | |
| K150129 | Aeu-7000L-70V Implant/endodontic Dental System (Lighted Version) | Aseptico, Inc. | EKX | Class I | |
| K143285 | Mandible External Fixator - MR Conditional | Synthes (USA) Products LLC | MQN | Class II |