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 |
|---|---|---|---|---|---|
| K010821 | Echoseed/iodine-125 Seeds, Model 6733 | Medi-Physics Inc. dba Nycomed Amersham Imaging | KXK | Class II | |
| K010795 | Capnoprobe Sl, Model 2000 | Optical Sensors, Inc. | CCK | Class II | |
| K010786 | Ulnar Head Implant | Avanta Orthopaedics, Inc. | KXE | Class II | |
| K010757 | Lfit V40 Femoral Head Components | Howmedica Osteonics Corp | JDI | Class II | |
| K010720 | Tsrh Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K010693 | Vigil Dnase B Control | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K010462 | Avita Piccolo/exato Infared Ear Thermometer (Ts2 & Ts4 Series) | Avita Corporation | FLL | Class II | |
| K010296 | Uterine Manipulator Injector Cannula, Model R57-450 | Marina Medical Instruments Inc. | LKF | Class II | |
| K010114 | Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color) | Johnson & Johnson Vision Care, Inc. | LPL | Class II | |
| K010104 | Candela Long Pulse Nd:yag | Candela Corporation | GEX | Class II | |
| K003463 | Socon Spinal System | Aesculap Inc | MNH | Class II | |
| K003326 | Funet Amy Mama Body Thermometer | Funai Radio & Communications Corp. | FLL | Class II | |
| K003126 | Bipolar Trigger-Flex Probe | Ellman Intl., Inc. | GEI | Class II | |
| K002997 | Fiesta Imaging Option | GE Healthcare | LNH | Class II | |
| K010784 | Plato Srs Stereotactic Radiosurgery Planning System,model 2.0, Plato Ifs Image Fusion Software, Model 2.1 | Nucletron BV | MUJ | Class II | |
| K010779 | Modification To:laparoscopic/endoscopic Instrument | Gibbons Surgical Corp. | FHO | Class II | |
| K010767 | Lifeport Vtx Access System,model Vtx 7000 Series | Boston Scientific Corporation | LJT | Class II | |
| K010719 | Powder-Free Nitrile Patient Examination Glove, Purple Color | Perusahaan Getah Asas Sdn. Bhd. | LZA | Class I | |
| K010489 | Dyonics Vision 111 Mobile Video Unit | Smith & Nephew, Inc. | GCJ | Class II | |
| K010486 | Polymer Coated Powder-Free Grey Color Polychloroprene Patient Examination Gloves | PT. Medisafe Technologies | LZA | Class I | |
| K003731 | Safesheath Msp Introducer Sheath Kit with Integral Hemostasis Valve | Merit Medical Systems, Inc. | DYB | Class II | |
| K002000 | Multifuction Suction Irrigation System, Existing of Suction Irrigation Handles, Suction Irrigation Tubes, and Tube Sets; | Richard Wolf Medical Instruments Corp. | GEI | Class II | |
| K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | OTO | Class II | |
| K010909 | Nonabsorbable Polypropylene Surgical Suture | Tyco Healthcare Group LP | GAW | Class II | |
| K010830 | Powder Free Textured Vinyl Examination Gloves | General Gloves Corp. | LYZ | Class I | |
| K010671 | Powder Free Synthetic Vinyl Patient Exam Glove | Tong Ruhn Medical Products Co., Ltd. | LYZ | Class I | |
| K010570 | Breast Immobiization and Biopsy Device Mr-Biopsy 160 | Mri Devices Corp. | LNH | Class II | |
| K010569 | Ksea Universal Laparomat Laparoscopic Suction and Irrigation Pump | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K010488 | Atac Pak Ast Reagent Kit | Elan Holdings, Inc. | CIT | Class II | |
| K010363 | Etest Meropenem | Ab Biodisk | JWY | Class II | |
| K010350 | Sta -Calibrator Hbpm/lmwh Kit | Diagnostica Stago, Inc. | GGN | Class II | |
| K010328 | Multiple (Izon DNA Blood Collection Kit) | Izon Business Products, Inc. | PJE | Class II | |
| K010324 | Sta-Quality Hbpm/lmwh Kit | Diagnostica Stago, Inc. | GGN | Class II | |
| K010265 | Baylis Medical RF Perforation Probe, Model Rfp-265 | Baylis Medical Co., Inc. | GEI | Class II | |
| K010220 | Xtractor, Model M143 | Instruments Medicaux G.B., Inc. | GCJ | Class II | |
| K010164 | Icg Module | General Electric Medical Systems Information Techn | DSB | Class II | |
| K010086 | Real Patient Excel Neurowork, Model Ex-Rp-EEG (Proposed) | Excel Tech., Ltd. | GWQ | Class II | |
| K003830 | ENT Endoscopes | Global Endoscopy, Inc. | EOB | Class II | |
| K003676 | Rita Model 2500 Electrosurgical RF Generator | Boston Scientific Corporation | GEI | Class II | |
| K003527 | Modification to Synthes (USA) Polypin | Synthes (USA) Products LLC | HTY | Class II | |
| K003494 | Mimix Bone Replacement System | Zimmer GmbH | LYC | Class II | |
| K002981 | Ultracision Harmonic Scalpel Coagulating Shears, Model Lcsc5,lcsc1,cs23c,cs231,cs14c,cs141,lcsb5,lcsk5,lcs15,lcs16,cs150 | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K002902 | Tandem-Cath 10 Fr. Catheter System, Model Multiple Code Numbers | Kendall | MSD | Class II | |
| K001352 | Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit | Corgenix, Inc. | DHC | Class II | |
| K010924 | Modification to Plum Xl Infusion Pump | Abbott Medical | FRN | Class II | |
| K010883 | Teratech Model 8Ec4 Endocavity Smart Probe | Teratech Corp. | ITX | Class II | |
| K010801 | T2 Femoral Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K010776 | Trinity Polyaxial Screw, Mehdian Spinal Rod (6Mm), Model 159.Xxx Series Catalogue Numbers | Corin USA | MNH | Class II | |
| K010171 | Duraloc Acetabular Cup System, 36Mm Marathon +4 Polyethylene Liner | Depuy Orthopaedics Inc. | LPH | Class II | |
| K010124 | Arthrex Univers 30 Shoulder Prosthesis | Arthrex GmbH | KWS | Class II |