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 |
|---|---|---|---|---|---|
| K052872 | Idoc Upper Arm Attached Blood Pressure and Pulse Rate Monitor, Model Id-42A/id-43A | Taidoc Technology Corporation | DXN | Class II | |
| K052834 | Mreye Embolization Coil | Cook Inc. | KRD | Class II | |
| K052745 | Assisto Arm Systems | Geomed Medizin-Technik GmbH & Co. KG | GWG | Class II | |
| K052561 | Terumo Micro Tapered Pen Needle | Kofu Factory of Terumo Corp. | FMI | Class II | |
| K052455 | Impressix | Cavex Holland B.V. | ELW | Class II | |
| K052391 | Vision (with Off-Line Review) | Varian Medical Systems, Inc. | IYE | Class II | |
| K052335 | Analgesia Gas Machine, Model Digital Ultra | Accutron Inc | BSZ | Class II | |
| K052304 | Super Porcelain Ex-3 Press | Noritake Co., Inc. | EIH | Class II | |
| K052264 | Quanta Lite Ccp3 Igg Elisa | Inova Diagnostics, Inc. | NHX | Class II | |
| K052257 | Vascular Solutions Twin-Pass Dual Access Catheter | Vascular Solutions LLC | DQY | Class II | |
| K052255 | Arcomxl Polyethylene Rx90 Acetabular Liners | Zimmer GmbH | LPH | Class II | |
| K052218 | Crono Five and Crono Pca 50 | Cane S.r.l. | FRN | Class II | |
| K051963 | Be-Certain Pregnancy Test | Natureplex LLC | LCX | Class II | |
| K051734 | Ge Healthcare Insta Trak 3500Plus/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955 | GE Healthcare Technologies | HAW | Class II | |
| K051672 | Powerpicc | Bard Access Systems, Inc. | LJS | Class II | |
| K051455 | Wieslab Cap Mpo-Anca | Eurodiagnostica | MOB | Class II | |
| K051299 | Igd Diagnostic Test Kits | The Binding Site | CZJ | Class II | |
| K051102 | Omnipicc Pi | Boston Scientific Corporation | LJS | Class II | |
| K050800 | Niki T34 and Bodyguard T34 Syringe Drivers | Caesarea Medical Electronics, Ltd. | FRN | Class II | |
| K050209 | Smith & Nephew Control Digital Operating Room System | Smith & Nephew, Inc. | GCJ | Class II | |
| K043048 | Grafton Plus Dbm Paste | Osteotech Inc | MBP | Class II | |
| K053038 | Hoffmann II Compact MRI External Fixation System | Howmedica Osteonics Corp | KTT | Class II | |
| K053027 | Vsm Vital Signs Monitor, Model 53000 (Vsm 300) | Welch Allyn Inc | MWI | Class II | |
| K053010 | Vistadent at Complete, Model 3.1 | Dentsply Intl. | LLZ | Class II | |
| K053003 | Depuy Cmw 1, 2 and 3 Bone Cements | Depuy Orthopaedics Inc. | LOD | Class II | |
| K053002 | Depuy Cmw 1 Gentamicin Bone Cement | Depuy Orthopaedics Inc. | MBB | Class II | |
| K052977 | Datex-Ohmeda S/5 Cardiac Output and Svo2 Module, E-Copsv and Accessories | GE Healthcare | DQK | Class II | |
| K052879 | Nexgen Complete Knee Solution Mis Modular Tibial Plates and Keels | Zimmer GmbH | JWH | Class II | |
| K052874 | Soprano Hair Removal Diode Laser | Msq (M2), Ltd. | GEX | Class II | |
| K052784 | Device Connectivity Software Developers Kit (Sdk), Model 4500-900 | Welch Allyn Inc | DXN | Class II | |
| K052612 | Disposable Powder Free Vinyl Exam Gloves with Vitamin Complex, Nopal and Lanolin Blue Color | Shanghai Antares Industries, Inc. | LYZ | Class I | |
| K052524 | Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit | Medtronic Perfusion Systems | DWF | Class II | |
| K052374 | Rapid Progeammer 3.0 | Abbott Medical | GZB | Class II | |
| K052196 | Vilex X-Fix | Vilex, Inc. | KTT | Class II | |
| K052092 | Rps Adeno Detector | Rapid Pathogen Screening, Inc. | GOD | Class I | |
| K052059 | Iui Catheter, Model 9057 | Inntec, Inc. | MQF | Class II | |
| K051458 | Wieslab Cap Pr-3 Anca | Eurodiagnostica | MOB | Class II | |
| K051161 | Quest Diagnostics Haircheck-Dt (Amphetamines) | Quest Diagnostics, Inc. | DKZ | Class II | |
| K051034 | Uryxxon 200 Urine Analyzer | Macherey Nagel GmbH & Co. KG | JIL | Class II | |
| K053045 | Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 | Integra LifeSciences Corporation | HBL | Class II | |
| K053000 | Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat) | Haemonetics Corporation | CAC | Class II | |
| K052837 | Sensiflex Plus Polymer Coated Latex Powder-Free Surgical Glove with Aloe Vera | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K052702 | Misonix Inc. Fs-1000-RF Bipolar Forceps Accessory | Misonix, LLC | GEI | Class II | |
| K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | DTL | Class II | |
| K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/zz | Polyganics B.V. | LYA | Class I | |
| K051836 | Skelite Resorbable Cement Restrictor | Millenium Biologix, Inc. | JDK | Class II | |
| K053151 | Rubicor Magic Breast Biopsy Device | Rubicor Medical, Inc. | KNW | Class II | |
| K053043 | Encompass Software Package | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K052961 | The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, and Mp90 Intellivue Patient Monitors, with 802.11 Wireless Lan | Philips North America LLC | DRG | Class II | |
| K052905 | Modification to Coulter Lh 750 Hematology Analyzer | Siemens Healthcare Diagnostics Inc. | GKZ | Class II |