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 |
|---|---|---|---|---|---|
| K070060 | Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece) | Welch Allyn Inc | DXQ | Class II | |
| K073186 | Synthes 3.5Mm Lcp Clavicle Plate System | Synthes (USA) Products LLC | HRS | Class II | |
| K071876 | Cross.bone | Trimed Inc | MQV | Class II | |
| K071679 | Metafix and Fixion Fa Intramedullary Nailing Systems | Disc-O-Tech Medical Technologies, Ltd. | HSB | Class II | |
| K073409 | Omniguide Sterile Waveguide Adapter System | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K073284 | Air-Flow Master Standard | (Ems Sa) Electro Medical Systems | EFB | Class I | |
| K073251 | Hyalomatrix Pa | Fidia Advanced Biopolymers SRL | QSZ | Unclassified | |
| K073043 | Set Pp | Sdi, Ltd. | EMA | Class II | |
| K072832 | Anterolateral and Medial Locking Plating System | Depuy Orthopaedics Inc. | HRS | Class II | |
| K072823 | Merilas 532A | Meridian AG | HQF | Class II | |
| K072657 | Power Port-a-Cath, Cath II, and P.a.s. Port T2 Power P.a.c. Implantable Venous Access Systems and Power Gripper Plus | Abbott Medical | LJT | Class II | |
| K072654 | Patient Safe Syringe | Retractable Technologies, Inc. | FMF | Class II | |
| K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | NGX | Class II | |
| K072552 | Merit Medical Systems, Inc., Guide Wire Torque Device | Merit Medical Systems, Inc. | DQX | Class II | |
| K072476 | Through-the-Peg (Ttp) Jejunostomy Tube Kit | Boston Scientific Corporation | KNT | Class II | |
| K072377 | Disposable Powder Free Vinyl Synthetic Exam Glove, White Color | Xuzhou Full Sun Medical Products Ltd. | LYZ | Class I | |
| K072154 | Foundation (Fmp) Porous Coated Spiked Acetabular System | Encore Medical, LP | LPH | Class II | |
| K072009 | Weinmanncompact, Model Wm 27380; Weinmannclick2, Model Wm 27340 | Weinmann Gerate Fur Medizin GmbH + Co. KG | BZD | Class II | |
| K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | LZG | Class II | |
| K071400 | Smartsite Stopcock | Cardinal Health, Alaris Products | FMG | Class II | |
| K071353 | Foshion Chair Mounted Dental, Model Fj48c | Shanghai Foshion Medical Instruments Co., Ltd. | KLC | Class I | |
| K070722 | Plasmair, Model T2006 | Airinspace B.V. | FRF | Class II | |
| K063243 | Vidas Troponin I Ultra (Tniu) Assay, Model 30 448 | bioMerieux, Inc. | MMI | Class II | |
| K073172 | Beacon Stabilization System | Globus Medical, Inc. | NKB | Class II | |
| K073049 | Screwplus Dental Implants (Ha) | Implant Direct, LLC | DZE | Class II | |
| K073040 | Smh Flex S | Smh Biomaterial AG | EBI | Class II | |
| K072940 | Mirage Micro | ResMed Corp | BZD | Class II | |
| K072911 | Ion Medical Bipolar Coagulation Pen | Ion Medical Inc | GEI | Class II | |
| K072866 | Issys Lp Spinal Fixation System | Custom Spine, Inc. | KWP | Class II | |
| K072759 | Vial2bag | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K072670 | Modification to: Eflow Electronic Inhaler/nebulizer | Pari Innovative Manufacturers, Inc. | CAF | Class II | |
| K072625 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | Cook Inc. | LJS | Class II | |
| K072621 | Esophageal/rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor | Gentherm Medical, LLC | BZT | Class II | |
| K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus ACMI, Inc. | FGA | Class II | |
| K072555 | Edta Plus | Essential Dental Systems, Inc. | KJJ | Unclassified | |
| K072511 | Swabable Vial Adapter 13Mm, Swabable Vial Adapter 20Mm | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K072375 | Smartport CT Mp Port Access System and Lifeguard CT Safety Infusion Set | Boston Scientific Corporation | FPA | Class II | |
| K071746 | Derma Prene Pi or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves | Ansell Healthcare Products LLC | KGO | Class I | |
| K070899 | Puritan Bennett Legendair Xl2 | Medtronic, Inc. | CBK | Class II | |
| K070783 | Sopro Model 640 Laparoscopic Insufflator | Sopro | HIF | Class II | |
| K070225 | Supracor Intr-Aortic Balloon Pump Console | Abiomed, Inc. | DSP | Class II | |
| K063642 | Fd Ems, Model # D-Fj30e | FUJI Dynamics Limited | IPF | Class II | |
| K073394 | Smartlipo Laser | Cynosure, LLC | GEX | Class II | |
| K073248 | Modification To:mako Surgical Unicondylar Knee System | Mako Surgical Corp. | HSX | Class II | |
| K073210 | Modification to: T-Port Hp Infusion Port | PFM Medical GmbH | LJT | Class II | |
| K073005 | Elite Glass | Zhermack S.p.A. | ELW | Class II | |
| K072804 | Comprehensive Rs Shoulder System | Biomet Manufacturing Corp | PHX | Class II | |
| K072765 | Passeo 18 | BIOTRONIK AG | LIT | Class II | |
| K072717 | Dimension Vista System Bilirubin Calibrator, Model Kc210 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K072660 | Endure Implant, Model 5108, 5111, 5113, 5114 | Imtec Corp. | DZE | Class II |