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 |
|---|---|---|---|---|---|
| K012369 | Basic, Models Basic 1, Basic 2, and Basic 3 | Atys Medical | IYN | Class II | |
| K012330 | Simplicity Euro Qd Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K012248 | Chase Cardiovascular Patch | Chase Medical, Inc. | DXZ | Class II | |
| K012239 | Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound Scanner; Sp-711 Sonoprobe System | Hitachi Medical Corp. | IYN | Class II | |
| K012170 | Digora Pct | Soredex Palodex Group Oy | MUH | Class II | |
| K012155 | Kodak Radiation Oncology Software/ for Acr Systems | Eastman Kodak Company | LLZ | Class II | |
| K012073 | Olympus Spray Catheter Pw-6C-1 | Olympus Optical Co., Ltd. | EOQ | Class II | |
| K011928 | Hydrotower Arthroscopic Administration Tubing Set, Model 7-460-05 | Northgate Technologies Inc. | FPA | Class II | |
| K011843 | Genzyme Direct-Amylase Test Reagent | Genzyme Corporation | JFJ | Class II | |
| K011840 | Cervilenz Uterine Measuring Sound | Cervilenz, Inc. | HHM | Class I | |
| K011621 | Koala Clamp, Koala Clamp and Cutter | Maternus, Inc. | HFW | Class II | |
| K011607 | Spermcatch | Nidacon International AB | MQL | Class II | |
| K011513 | Mp3u, Power Wheelchair | Merits Health Products, Inc. | ITI | Class II | |
| K011496 | Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660 | Richard Wolf Medical Instruments Corp. | FBO | Class II | |
| K011484 | Olympus Injector Nm-4-1, Nm-5-1, Nm-6-1, Nm-7-1, Nm-8-1, Nm-9-1 | Olympus Optical Co., Ltd. | FBK | Class II | |
| K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf Id | Medtronic Functional Diagnostics A/S | FFX | Class II | |
| K011467 | Ross Embrace Pump Set | Ross Products | KNT | Class II | |
| K011176 | Reusable Glass Syringes | Lockett Medical Corp. | FMF | Class II | |
| K011024 | Cyberknife System | Accuray Incorporated | IYE | Class II | |
| K010544 | Vertex L/c Orthodontic Direct Bonding Paste | Apex Dental Materials, Inc. | DYH | Class II | |
| K010039 | Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution | Chronimed, Inc. | NBW | Class II | |
| K003631 | Smartwave If 2000 | Newwave Medical, LLC | LIH | Class II | |
| K012373 | Liferay Wl Cassette, Liferay Kw Cassette | Ferrania S.p.A. | IXA | Class II | |
| K012355 | Image-X System | Tg Group, Inc. | EHD | Class II | |
| K012210 | Modification to Accu-Chek Inform Meter | Roche Diagnostics GmbH | NBW | Class II | |
| K012198 | Gibbons Sterile Trocar Kits | Gibbons Surgical Corp. | FBQ | Class II | |
| K011978 | Synthes Lcp Proximal Tibia Plate | Synthes (USA) Products LLC | HRS | Class II | |
| K011962 | Advantage Marijuana (Thc) and Cocaine Home Drug Test | Advantage Diagnostics Corp. | DIO | Class II | |
| K011730 | Acon Pcp One-Step Phencyclidine Test Strip, Acon Pcp One-Step Phencyclidine Test Device | Acon Laboratories, Inc. | LCM | Unclassified | |
| K011665 | Bct System | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K011571 | Trxf Intelligent Dosing System (Ids) -Dosing Calculator Suite | The RX Files Corp. | NDC | Class II | |
| K011538 | Endopath Non-Bladed Solid Obturator Trocar System | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K011320 | Etg-100 Optical Encephalography System | FUJIFILM Healthcare Americas Corporation | DQA | Class II | |
| K010807 | Muscle Stimulator Sa-100 | Health@Fitness Technologies, Inc. | IPF | Class II | |
| K010702 | Xub External Ultrasound | Kmi Kolster Methods, Inc. | IMI | Class II | |
| K003714 | Osstell Resonance Frequency Analyzer | Integration Diagnostics, Ltd. | EKX | Class I | |
| K002890 | Intralase 600C Laser Keratome | Intra Lase Corp. | GEX | Class II | |
| K012286 | Modification To:cobas Integra Hdl-Cholesterol Plus 2Nd Generation | Roche Diagnostics GmbH | LBS | Class I | |
| K012054 | Full Auto Wrist Digital Blood Pressure Monitor, Model Se-312 | Sein Electronics Co., Ltd. | DXN | Class II | |
| K011935 | Rejuvenique Model #Rjv10 | Salton, Inc. | NFO | Class II | |
| K011444 | Anspach Emax Drill System | The Anspach Effort, Inc. | HBC | Class II | |
| K012313 | CT Colonography/navigator2 | GE Healthcare | JAK | Class II | |
| K012287 | Modification to: Cobas Integra Ldl-Cholesterol Plus 2Nd Generation | Roche Diagnostics GmbH | MRR | Class I | |
| K012215 | Quik-Check Home Pregnancy Test | Acon Laboratories, Inc. | LCX | Class II | |
| K012134 | Gc E-Light | GC America Inc. | EBZ | Class II | |
| K011822 | Pit and Fissure Chemical Curing Sealant | Rite-Dent Manufacturing Corp. | EBC | Class II | |
| K011807 | Scs Claris Spinal Screws, Types V,g,e | Ortho Tec, LLC | MNI | Class II | |
| K011695 | Collagen Dental Membrane | Collagen Matrix, Inc | NPL | Class II | |
| K011527 | Praxsys Relia Tsh Test | Praxsys Biosystems, Inc. | JLW | Class II | |
| K011460 | Wujin #3 Tibial Bone Plate | Biopro, Inc. | HRS | Class II |