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 |
|---|---|---|---|---|---|
| K911139 | Hewlett-Packard Models M1400a, M1402a & M1401a | Hewlett-Packard Co. | DRT | Class II | |
| K911104 | Photcoagulator Kr-568 Laser Spectrum Elite K1 | Hgm Medical Laser Systems, Inc. | FEX | Class I | |
| K910942 | Ac Powered and Battery Powered Medical Exam. Light | Mdt Biologic Co. | FSS | Class II | |
| K910696 | Cusa(r) System 200C/200t/200m/200h Ultra Aspirator | Medtronic, Inc. | LFL | Unclassified | |
| K905522 | Labsonics Mamm-O-Mate Model No. 918084-1, Modified | Laboratory Equipment Corp. | IYO | Class II | |
| K905056 | Percor Stat-Dl 9.5 Fr W/opt Insert W/o Intro Sheat | Datascope Corp. | DSP | Class II | |
| K912055 | Syva Edms | Syva Co. | JJF | Class I | |
| K912016 | Il Phoenix(tm), Model 905 Chem/elect Analyzer | Instrumentation Laboratory Co. | JGS | Class II | |
| K911937 | Osteomed Ib Drill | Osteomed | EFB | Class I | |
| K911854 | Dade Liid-Trol Tl Tri-Level Lipid Control | Baxter Healthcare Corporation | JJY | Class I | |
| K911571 | Epstein-Barr Virus Vca-Igg Antibody Elisa Test | Ortho Diagnostic Systems, Inc. | MCD | Class I | |
| K911570 | Epstein-Barr Virus Vca-Igm Antibody Elisa Test | Ortho Diagnostic Systems, Inc. | MCD | Class I | |
| K911569 | Epstein-Barr Virus Ebna-Igg Antibody Elisa Test | Ortho Diagnostic Systems, Inc. | LLM | Class I | |
| K911367 | Baxter Marathon(tm) Intravascular Relay Guid Cath | Baxter Healthcare Corporation | DQO | Class II | |
| K911347 | Lyphochek(r) Hemoglobin A2 Control | Bio-Rad | JCM | Class II | |
| K911330 | Lyme Igm Microassay | Diamedix Corp. | LSR | Class II | |
| K911310 | Corometrics 5566Aax Noninvasive Blood Pressure Mod | GE Medical Systems Information Technologies, Inc. | DXN | Class II | |
| K911294 | Ultraset Catheter | Dhd Diemolding Healthcare Div. | BZA | Class I | |
| K911287 | Pulpdent Seal Rite | Pulpdent Corporation | EBC | Class II | |
| K911196 | Schneider Total Cross .021 Percu Trans Angio (Pta) | Schneider Intl., Ltd. | LIT | Class II | |
| K911191 | Palco Labs Model 300 Oxygen/pulse Monitor | Palco Laboratories, Inc. | DQA | Class II | |
| K911112 | Device Part Numbers: - 1400 Series | Minimatic Implant Technology | DZE | Class II | |
| K911107 | Sonarscan 128 Ultrasound Scanner | Diagnostic Sonar USA | IYO | Class II | |
| K911091 | Diagnostic Ultrasound/uro-Gyn Uds 2000 Series | Diagnostic Ultrasound Corp. | FAP | Class II | |
| K911059 | Turbidometric Standard | Scientific Device Laboratory, Inc. | LIE | Class II | |
| K910899 | Lyme Disease Microassay | Diamedix Corp. | LSR | Class II | |
| K910720 | Bard Biopty-Cut Biopsy Needle with Spacer | C.R. Bard Inc | FCG | Class II | |
| K910710 | Radioactive Seeds | Best Assoc. Corp. | KXK | Class II | |
| K910451 | Card Guard, Model Cg-2000A | Medtech Industries, Inc. | DXH | Class II | |
| K910444 | Browne Medical Systems Imagepro | Browne Medical Systems, Inc. | FAP | Class II | |
| K905825 | Collagen Shield, Various Models | Chiron Ophthalmics | MOE | Class I | |
| K905753 | Qdr-1000 and Qdr-1000/W X-Ray Bone Densitometer | Hologic, Inc. | KGI | Class II | |
| K905500 | Myocardial Protection System | Medtronic, Inc. | DTR | Class II | |
| K905409 | Eia for Detection of Antibodies H. Pylori | E-Z-EM, Inc | LYR | Class I | |
| K905303 | Abutment Glo | Implant Innovations International, Inc. | EJR | Class I | |
| K905292 | System 50 | Folio Products, Inc. | ITI | Class II | |
| K904246 | System 70 and 100 | Folio Products, Inc. | ITI | Class II | |
| K903089 | Babylog 8000 Infant Ventilator | Drager, Inc. | CBK | Class II | |
| K912339 | Philips M30 in-the-Ear Hearing Aid | Philips Hearing Instruments Co. | ESD | Class I | |
| K912175 | Isotechnologies Liftstation & Liftworks Software | Isotechnologies, Inc. | INK | Class II | |
| K912037 | Degulux Light Curing Unit | Degussa AG | EBF | Class II | |
| K911852 | Compulse CO2 Surgical Laser Sys. | Laser Engineering, Inc. | GEX | Class II | |
| K911742 | Op-D-Op Visor Shields | Op-D-Op, Inc. | LYU | Class I | |
| K911714 | Kodak M35-Mx-0Mat Processor | Eastman Kodak Company | IXW | Class II | |
| K911713 | Kodak 100-J & 100-K Chemical Mixers | Eastman Kodak Company | IXW | Class II | |
| K911711 | Kodak Automatic Film Feeder, Model Ra | Eastman Kodak Company | IXW | Class II | |
| K911124 | 503 Pulse Oximeter | Criticare Systems, Inc. | DQA | Class II | |
| K910715 | Vista Hpq System | Philips North America LLC | LNH | Class II | |
| K910156 | Hydroxyapatite Coated Profile(r) Hip Stem | Depuy, Inc. | MEH | Class II | |
| K905632 | Nicolet Mapleleaf System | Nicolet Instrument Corp. | GWJ | Class II |