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 |
|---|---|---|---|---|---|
| K071442 | Suprasorb a +Ag | Specialty Fibres and Materials, Ltd. | FRO | Unclassified | |
| K080928 | Xia Spinal System, Stainless Steel Uni-Planar Screws | Howmedica Osteonics Corp | NKB | Class II | |
| K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151 | St. Jude Medical, Cardiac Rhythm Management Divisi | DRB | Class II | |
| K080845 | Orwell Fluid Collection and Disposal System | Cardinalhealth | JCX | Class II | |
| K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>firmware Upgrade, Emax 2 Fp Foot Pedal | The Anspach Effort, Inc. | HBE | Class II | |
| K080791 | Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and B011-45 | Senorx, Inc. | JAQ | Class II | |
| K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy Claim | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K080429 | Modificaton to: Pyramid +4 Anterior Lumbar Plate System | Medtronic Sofamor Danek USA Inc | KWQ | Class II | |
| K080418 | Regenafil, Regenaform, Alriva Dbm Paste, Sltiva Dm with Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NUN | Class II | |
| K080396 | Osseospeed Narrow | Astra Tech, Inc. | DZE | Class II | |
| K080392 | EndoWave Infusion System | Ekos Corp. | QEY | Class II | |
| K080331 | Synthes Craniofacial Plate and Screw System | Synthes (USA) Products LLC | JEY | Class II | |
| K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings | Straumann USA, LLC | NHA | Class II | |
| K080201 | Vitek 2 Gram Positive Inducible Clindamycin Resistance | bioMerieux, Inc. | LON | Class II | |
| K080085 | Mas Tox Control | Thermo Fisher Scientific Oy | DIF | Class I | |
| K073614 | Wg-Surgical Sutures with Needle | Foosin Medical Supplies Inc., Ltd. | NEW | Class II | |
| K073471 | Vantagecath Intravascular Catheter | Advantage Medical Device | FOZ | Class II | |
| K072930 | Demetech Absorbable Surgical Suture Plain & Chromic Gut | Demetech Corp. | GAL | Class II | |
| K072408 | Emu-Graph Emulator, Model Ci 131 | Steritec Products Mfg. Co., Inc. | JOJ | Class II | |
| K081135 | Gemini Condor | Philips North America LLC | KPS | Class II | |
| K081047 | Transposal Ultra Systems | Dornoch Medical Systems | JCX | Class II | |
| K080968 | S-Scan, G-Scan, Dynamic MRI Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote S.p.A. | LNH | Class II | |
| K080890 | Smartspot Primax | CMT Medical Technologies, Ltd. | LLZ | Class II | |
| K080889 | Kodak 9000C Extraoral Imaging System | Trophy | MUH | Class II | |
| K080871 | Trocar Point Titanium Needle Sets, Round Point Titanium Needle Sets | Nucletron BV | JAQ | Class II | |
| K080790 | Modification to Theken Atoll Cervico-Thoracic System | Theken Companies LLC | KWP | Class II | |
| K080621 | Fastlock, Model Pc175m01, Pc175mce, Pc005r01 | Alto Development Corp | DSA | Class II | |
| K080317 | Enolok-for Endoscoped with 12.8>Dia.<13.3mm Shaft Diameter, Model Ael; Endoscopes with 11.3>Dia. 11.5Mm Shaft ,Model Pel | Syntheon, LLC | FDF | Class II | |
| K072379 | Mps Oxiport and Mps Oxiport Plus | Innerspace, Inc. | GWM | Class II | |
| K080925 | Fox Plus Pta Catheter | Abbott Vascular | LIT | Class II | |
| K080885 | Medacta Total Hip Prosthesis System - Line Extension | Medacta International SA | JDI | Class II | |
| K080329 | Cap Plus, Equivabone, Cap/dbm | Etex Corp. | MBP | Class II | |
| K080195 | Nacera Z and Nacera Z Medium | Doceram Medical Ceramics GmbH | EIH | Class II | |
| K073643 | Trans1 Axialif 2-Level or II System | Trans1 Incorporated | KWQ | Class II | |
| K073168 | Aesculap Primeline Container Ltd. | Aesculap Inc | KCT | Class II | |
| K071867 | Rapid Genotyping Assay -Cyp2c9 & Vkorc1, Model Catalog No. 006+0203 Gactga | Paragondx, LLC | ODV | Class II | |
| K081028 | Signa 3.0T Mr750 System | GE Healthcare | LNH | Class II | |
| K081018 | Syngo Dynamics Version 7.0 | Siemens Medical Solutions | LLZ | Class II | |
| K080956 | Modification to Vf Gel Plus | Coapt Systems, Inc. | MIX | Class II | |
| K080760 | Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound di | IYN | Class II | |
| K080743 | Lockbox for Use with Cadd Solis Infusion Pump | Abbott Medical | FRN | Class II | |
| K080690 | Manta Ray Anterior Cervical Plate System | Theken Companies LLC | KWQ | Class II | |
| K080408 | External Fixation Clamp 5.0 Mm Pin X9.5mm Rod, Model 1151-100, External Fixaton Clamp, 9.5Mm Rod | Advanced Orthopaedic Solutions, Inc. | KTT | Class II | |
| K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | Spectranetics Corp. | PNO | Class II | |
| K080141 | Pc ECG 1200W System | Norav Medical Ltd. | MWI | Class II | |
| K073600 | Comfortgel Full Face Mask | Respironics Inc., Sleep & Home Respiratory Group | BZD | Class II | |
| K073404 | Ifs Laser System | Intra Lase Corp. | GEX | Class II | |
| K073358 | Lumimed Series 5Mp Digital Flat Panel Display System, Model Mm50/mm50a | Heeyoung Co., Ltd. | LLZ | Class II | |
| K073356 | Paradigm Insulin Infusion Pump, Models Mmt-512, Mmt-712, Mmt-515 and Mmt-715 | Medtronic, Inc. | LZG | Class II | |
| K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model Mc-5 | Nipro Vascular Innovations Americas, Inc. | OGZ | Class II |