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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp | Medtronic, Inc. | GEI | Class II | |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | Abbott Medical | MRG | Class II | |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun US Inc. | NOP | Class II | |
| K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | BSO | Class II | |
| K153285 | Ems-200 | Meta Systems Co., Ltd. | EKX | Class I | |
| K153089 | 'cottony' II TAPE, PLEDGETS | Teleflexmedical, Inc. | GAT | Class II | |
| K162077 | Laparoscopic Spray Applicator with Spinning Luers | Micromedics, Inc. (D/B/A Nordson Medical) | GCJ | Class II | |
| K162075 | NICO TRIOwand | Nico Corporation | GEI | Class II | |
| K161791 | Aer-O-Scope Colonoscope System | GI View Inc. | FDF | Class II | |
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | LPN | Class II | |
| K161574 | Discovery MI | GE Healthcare | KPS | Class II | |
| K161336 | VSI StraitSet micro-introducer kit | Vascular Solutions LLC | DRE | Class II | |
| K161267 | Response BandLoc Spinal Fixation | Orthopediatrics Corp | OWI | Class II | |
| K161266 | Athena Breast Pump | Exploramed Nc7, Inc. | HGX | Class II | |
| K160382 | Ot Equator | Rhein'83 SRL | NHA | Class II | |
| K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | GXY | Class II | |
| K153573 | Converge | Biomedical Enterprises, Inc. | HRS | Class II | |
| K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | HSN | Class II | |
| K153283 | VivoSight Dx Topical OCT System | Michelson Diagnostics Ltd | NQQ | Class II | |
| K152890 | Saccadometer Plus, Saccadometer Advanced | Ober Consulting Sp. Z.O.O. | HLL | Class II | |
| K161955 | 5D Viewer | Samsung Medison Co., Ltd. | LLZ | Class II | |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific Ltd. | JJX | Class I | |
| K161575 | Affirm Lateral Arm Upright Biopsy Accessory | Hologic, Inc. | IZH | Class II | |
| K161240 | Rhythm View Workstation (non-streaming) | Abbott Electrophysiology | DQK | Class II | |
| K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac Ltd. | HQD | Class II | |
| K161066 | SpotLight CT | Arineta Ltd. | JAK | Class II | |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | Unomedical A/S | FPA | Class II | |
| K160565 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K160516 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths | Varian Medical Systems, Inc. | JAQ | Class II | |
| K160472 | Hidrocor, Hidrocharme, and Natural Colors | Solotica | LPL | Class II | |
| K160239 | Tap 3, Tap 1 | Airway Management Inc. | PLC | Class II | |
| K160147 | CT TrueView | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Euroimmun US Inc. | NOP | Class II | |
| K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 | Colonplus Equipments & Speculums, S.L. | KPL | Class II | |
| K161914 | Genesys Spine TiLock Cortical Spinal System | Genesys Spine | NKB | Class II | |
| K161148 | icobrain | icometrix | LLZ | Class II | |
| K161026 | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) | Marvao Medical Devices Ltd. | MSD | Class II | |
| K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet | Syncro Medical Innovations, Inc. | KNT | Class II | |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | Ark Diagnostics Inc | POX | Class II | |
| K153200 | SnoreRx | Apnea Sciences Corporation | LRK | Class II | |
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | LHN | Class II | |
| K152135 | Quantitative Electrocardiographic Detector (QED 2000) | Acme Portable Machines, Inc. | DPS | Class II | |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson & Co | MDB | Class I | |
| K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. C/O Linda Braddon, PhD | GXQ | Class II | |
| K160743 | Philips Ingenuity CT | Philips North America LLC | JAK | Class II | |
| K160679 | WoundClot9 | Core Scientific Creation, Ltd. | QSY | Unclassified | |
| K160611 | P-Artis | P-Cure, Ltd. | JAK | Class II | |
| K153742 | Apollo Balloon Dilatation Catheter | BrosMed Medical Co.,Ltd. | LOX | Class II | |
| K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet | Devicor Medical Products Inc | KNW | Class II | |
| K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove | Permeaderm, Inc. | FRO | Unclassified |