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 |
|---|---|---|---|---|---|
| K063719 | Arthrex Crosspin, Model Ar-1964P | Arthrex GmbH | HTY | Class II | |
| K063340 | Saf-T-Syringe- 0.5 and 1Ml/cc | Safety Medical International, Incorporated | MEG | Class II | |
| K062026 | Vap-Nt Cholesterol Test | Atherotech, Inc. | CHH | Class I | |
| K061971 | Zirconia Implant | Nobel Biocare AB | DZE | Class II | |
| K070077 | Ultrasound Scanner Profocus, Model 2202 | BK Medical ApS | IYO | Class II | |
| K063795 | Guardiancatheter-Urinary Drainage Catheter | Marian Medical, Inc. | GBM | Class II | |
| K063786 | Endoscopic Insufflation Unit, Model Xecr-2 | Olympus Medical Systems Corp. | FCX | Class II | |
| K063722 | Sekurit Sharps Collection Container | Techen Safety, Inc. | MMK | Class II | |
| K063676 | Dbx Demineralized Bone Matrix Mix | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | MBP | Class II | |
| K063673 | Innovacon Flipcard Fecal Occult Blood Test Device | Innovacon, Inc. | KHE | Class II | |
| K063512 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | IWB | Class II | |
| K063491 | T2 Sceptor Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K062480 | Joykey Surgical Drapes (Sterile) | Joykey Industryial, Ltd. | KKX | Class II | |
| K061706 | Cadwell Easynet Oximeter Module | Cadwell Laboratories, Inc. | DQA | Class II | |
| K061622 | Ps Series | Photonic Optische Gerate Gesmbh & Cokg | FFS | Class II | |
| K070373 | Apoza LED Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5W | Apoza Enterprise Co., Ltd. | EBZ | Class II | |
| K070312 | Earcheck Acoustic Reflectometer | Innovia Medical, LLC | ETY | Class II | |
| K070269 | Modification to Collawound Dressing | Collamatrix Co., Inc. | KGN | Unclassified | |
| K070170 | Dall-Miles System | Stryker Orthopaedics | HRS | Class II | |
| K070139 | Willson One-Fit Healthcare Particle Respirator and Surgical Mask, Hc-Nb095 | Survivair, Inc. | MSH | Class II | |
| K070089 | Syntermed Live | Syntermed, Inc. | LLZ | Class II | |
| K063792 | Osteomed External Mandibular Distraction System | Osteomed | MQN | Class II | |
| K063776 | Able Glove Latex Powdered Examination Gloves | Bright Element Sdn Bhd | LYY | Class I | |
| K063734 | Atlantis Abutment in Zirconia for 3I Certain Interface | Atlantis Components, Inc. | NHA | Class II | |
| K063731 | Advance Stature Femoral Component | Wrightmedicaltechnologyinc | MBH | Class II | |
| K063698 | CO2 Laser System, Model C-Las | Clinicon Corp. | GEX | Class II | |
| K063633 | Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves | Depuy Orthopaedics Inc. | JWH | Class II | |
| K063588 | Matryx Interference Screw, 239038T5,231025t5,231033t5,231038t5,231125t5,231133t5,231138t5 | Conmed Linvatec Biomaterials | HWC | Class II | |
| K063578 | Promos Modular Shoulder System | Plus Orthopedics | HSD | Class II | |
| K063466 | Top Fine | Daejin Tech Medical Manufacturing Co., Ltd. | FMI | Class II | |
| K063298 | Osteomed Headless Cannulated Screw System | Osteomed | HWC | Class II | |
| K062085 | S4 Spinal System | Aesculap Inc | NKB | Class II | |
| K060899 | Flexilux II Cystoscope and Hysteroscope | Schoelly Imaging, Inc. | FAJ | Class II | |
| K070294 | Synthes Trochanteric Fixation Nail (Tfn) System, Additional Helical Blades | Synthes (USA) Products LLC | HSB | Class II | |
| K070248 | Velocityais | Varian Medical Systems, Inc. | LLZ | Class II | |
| K070176 | Maxhealth Mechanical Wheelchair, K1 | Maxhealth Corp. | IOR | Class I | |
| K070114 | Creation Cp-Zi Porcelain | Jensen Industries, Inc. | EIH | Class II | |
| K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | MIX | Class II | |
| K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | PAH | Class II | |
| K063847 | Fujinon Ultrasonic Endoscope and Processor, Models Eg-530Ur, Eg-530Ut and Su-700 | FUJIFILM Healthcare Americas Corporation | FDS | Class II | |
| K063815 | Varian Esophagus Bougie Applicator | Varian Medical Systems, Inc. | JAQ | Class II | |
| K063449 | Deluxe Nebulizer | Access Point Medical, LLC | CAF | Class II | |
| K063390 | Urine Chemistry Analyzer Ur-50 | Ind Diagnostic, Inc. | JIL | Class II | |
| K063348 | Top Fine Insulin Syringe | Daejin Tech Medical Manufacturing Co., Ltd. | FMF | Class II | |
| K062840 | Triage Protein C Controls and Calibration Verification Controls | Biosite Incorporated | GGN | Class II | |
| K062792 | Erchonia Ioto_240 | Erchonia Medical, Inc. | EGJ | Class II | |
| K062762 | Derma Yag | El.en. Electronic Engineering SpA | GEX | Class II | |
| K062214 | Brachysciences Strandport | Worldwide Medical Technologies, LLC | KXK | Class II | |
| K070400 | Lc Therapy, Model Lct-1000 | LiteCure, LLC | ILY | Class II | |
| K070238 | Amplatzer Reliant Catheter Delivery System | Abbott Medical | DQY | Class II |