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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K142594 | nva, nvp, nvt | Nvision Biomedical Technologies, Inc | MAX | Class II | |
| K140041 | Zen-7000,System,fluroscopic X-Ray System | Genoray Co., Ltd. | OWB | Class II | |
| K143091 | Surgisleeve Wound Protector | Medtronic, Inc. | GCJ | Class II | |
| K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K142938 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | HRS | Class II | |
| K142695 | Cytosponge Cell Collection Device | Medtronic, Inc. | EOX | Class II | |
| K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid | PCH | Class II | |
| K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | HIH | Class II | |
| K141741 | Aquilion Prime, V6.00 | Toshibamedical Systems Corporation | JAK | Class II | |
| K141408 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | FGE | Class II | |
| K141158 | Apex | Incontrol Medical, LLC | KPI | Class II | |
| K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | MSD | Class II | |
| K140859 | Dimension Vista Free Thyroxine Flex Reagent Cartridge, Ft4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent | Siemens Healthcare Diagnostics Inc. | CEC | Class II | |
| K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, Ft4l, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart | Siemens Healthcare Diagnostics Inc. | CEC | Class II | |
| K133434 | Genesis II | Dornier Medtech America, Inc. | JAA | Class II | |
| DEN130045 | Heartflow Ffrct | Heartflow, Inc. | PJA | Class II | |
| K143074 | Sherpa Pak Cardiac Transport System | Paragonix Technologies Inc. | MSB | Class II | |
| K143054 | Sherpa Pak Kidney Transport System | Paragonix Technologies Inc. | KDN | Class II | |
| K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex GmbH | PHX | Class II | |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | DXZ | Class II | |
| K142424 | Dr300 Holter Monitor | North East Monitoring, Inc. | MWJ | Class II | |
| K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | MWI | Class II | |
| K142393 | Predicate III Guidewire | Lake Region Medical | DQX | Class II | |
| K142389 | Variolink Esthetic | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K142367 | Hospira Primary Sets | Abbott Medical | FPA | Class II | |
| K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | OVE | Class II | |
| K142272 | SNaP Wound Care System | Spiracur, Inc. | OKO | Class II | |
| K142270 | Latex Powdered Examination Gloves with Protein Labeling Claim of 200 Microgram or Less per Gram of Glove | Hartalega Sdb. Bhd. | LYY | Class I | |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | GXH | Class II | |
| K142118 | Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare Branae | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| K142065 | Turnpike Catheter | Vascular Solutions LLC | DQY | Class II | |
| K141928 | Cobas C Acetaminophen Gen.2 Assay, Acet2 Calibrator | Roche Diagnostics Operations (Rdo) | DKB | Class II | |
| K141792 | Genesis Touch System | Honeywell Hommed, LLC | DRG | Class II | |
| K141537 | In:c2 Spinal Fixation Systme | Spine Smith Partners L.P. | OVE | Class II | |
| K141523 | Ally Ups | CooperSurgical, Inc. | LKF | Class II | |
| K141333 | Arena-C Tifuse Cervical Intervertebral Body Fusion Device | SPINEFRONTIER, Inc. dba LESspine Innovations | ODP | Class II | |
| K141231 | Zp9141, Zp9146y, Zp9146w Non-Rechargeable Battery | Zeller Power Products (Battery Beast, LLC) | MKJ | Class III | |
| K140768 | Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type III Brilliant Introducer Kit, Type IV Brilliant | Lepu Medical Technology (Bejing) Co., Ltd. | DYB | Class II | |
| K140535 | Philips Avalon Fetal / Maternal Monitors Fm20, Fm30, Fm40 and Fm50 | Philips Medizin Systeme Boblingen GmbH | HGM | Class II | |
| K140382 | Aeromini Tracheobronchial Stent Technology | Merit Medical Systems, Inc. | JCT | Class II | |
| K133989 | Ambulo 2400 Ambulatory Blood Pressure Monitoring System | Mortara Instrument, Inc. | DXN | Class II | |
| K142802 | Atlas SPEEDER Head/Neck | Quality Electrodynamics | MOS | Class II | |
| K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc | NPL | Class II | |
| K142467 | IntelAir Nasal Airway Support System | Abeon Medical Corporation | CCK | Class II | |
| K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System | Zimmer GmbH | KWS | Class II | |
| K142290 | KangLi pedical screw spinal system | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | MNH | Class II | |
| K142238 | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | HBL | Class II | |
| K142147 | Eeva System | Auxogyn, Inc. | PBH | Class II | |
| K142098 | Signa Pet/mr | GE Healthcare | OUO | Class II | |
| K142072 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Custom Orthopaedic Solutions, Inc. | KWS | Class II |