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 |
|---|---|---|---|---|---|
| K151171 | Traus Sus10 | Saeshin Precision Co., Ltd. | DZI | Class II | |
| K150977 | Cirrus Hd-Oct | Carl Zeiss Meditec Inc | OBO | Class II | |
| K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A | NUC | Class II | |
| K150239 | FibroScan | Echosens | IYO | Class II | |
| K152174 | Sniper Spine System | Spine Wave Inc | MNI | Class II | |
| K151459 | Integra Total Ankle Replacement System | Ascension Orthopedics, Inc. | HSN | Class II | |
| K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | MSX | Class II | |
| K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | NKB | Class II | |
| K150146 | Biogel PI Micro Indicator Underglove | Molnlycke Health Care, US LLC | KGO | Class I | |
| K150143 | Normal Saline Flush | Nurse Assist, LLC | NGT | Class II | |
| K143539 | Dental Implant OKTAGON Bone Level | Hager & Meisinger GmbH | DZE | Class II | |
| K152164 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | |
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System | Galil Medical Ltd. | GEH | Class II | |
| K151768 | Menicon Saline Rinse Solution | Menicon Co. Ltd. | LPN | Class II | |
| K151732 | Arthrex Fracture Plates | Arthrex GmbH | HRS | Class II | |
| K151319 | Eko Electronic Stethoscope System | Eko Devices, Inc. | DQD | Class II | |
| K151206 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | |
| K151088 | DMRC Bulk Fill | Danville Materials, Inc. | EBF | Class II | |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | DiaSorin Molecular LLC | OQO | Class II | |
| K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | DQY | Class II | |
| K150556 | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) | Thermo Fisher Scientific Oy | JWY | Class II | |
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | The Binding Site Group Ltd. | DAE | Class II | |
| K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical, LLC | LZU | Unclassified | |
| K150154 | ANAM Test System: Military Battery | Vista Lifesciences, Inc. | PKQ | Class II | |
| K143579 | NuVasive Sterilization Trays | Nu Vasive, Incorporated | KCT | Class II | |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm | Natus Manufacturing Limited | IKT | Class II | |
| K143424 | Utah Cvx-Ripe | Utah Medical Products, Inc | PFJ | Class II | |
| K152116 | 5.5 F Worley Advanced LVI Lateral Vein Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K151753 | 16 ch Tx/Rx Knee SPEEDER | Quality Electrodynamics | MOS | Class II | |
| K151740 | JAZZ System | Implanet | OWI | Class II | |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | Atrium Medical Corporation | FTL | Class II | |
| K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DTQ | Class II | |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) | Nonin Medical, Inc | MUD | Class II | |
| K150786 | Rezum System | Nxthera, Inc. | KNS | Class II | |
| K150771 | RxG Distraction System | KLS-Martin L.P. | PBJ | Class II | |
| K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | LRK | Class II | |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | Sterilmed Inc | NLH | Class II | |
| K150289 | Cardioline Hd+ | Cardioline S.p.A. | DRG | Class II | |
| K150040 | Implanova | Dental Evolutions, Inc | DZE | Class II | |
| K143738 | DSS Sinusplasty Balloon Catheter | Intuit Medical Products, LLC | LRC | Class I | |
| K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit | William A. Cook Australia Pty, Ltd. | MQL | Class II | |
| K143721 | Prct2 | Fx Shoulder Solutions SAS | HRS | Class II | |
| K143454 | Pruitt F3-S Carotid Shunt | LeMaitre Vascular Inc. | MJN | Class II | |
| K152165 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | |
| K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | Teleflexmedical, Inc. | FZP | Class II | |
| K152076 | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority | Stryker Corp. | GWO | Class II | |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) | Novabone Products, LLC | MQV | Class II | |
| K152070 | BioZorb LP Marker | Focal Therapeutics | NEU | Class II | |
| K151008 | Link® Megasystem-C® | Waldemar Link GmbH & Co. KG | KRO | Class II | |
| K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | MUH | Class II |