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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K232643 | Cue COVID-19 Molecular Test | Cue Health, Inc. | QWB | Class II | |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | KNS | Class II | |
| K232595 | Kinos Axiom Total Ankle System | restor3d, Inc. | HSN | Class II | |
| K232252 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) | Dehai (Shandong) Medical Gloves, Co., Ltd. | LZA | Class I | |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | Wuhan Lotuxs Technology Co.,Ltd. | GEX | Class II | |
| K232012 | N1 | OSSTEM Implant Co., Ltd. | EHD | Class II | |
| K232000 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K231631 | BriefCase-Quantification | Aidoc Medical Ltd. | JAK | Class II | |
| K231473 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | QNW | Class II | |
| K231250 | Digital Blood Pressure Monitor | Guangdong Genial Technology Co., Ltd. | DXN | Class II | |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics Inc. | LRK | Class II | |
| K230883 | VersaPump Infusion System | Emed Technologies Corporation | PKP | Class II | |
| K222845 | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | Frey Oral Technologies, LLC | MQC | Unclassified | |
| K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC | FMI | Class II | |
| K233332 | Statera-C™ Spinal System | K&J Consulting Corp. | NKG | Class II | |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro Inc. | HAW | Class II | |
| K233171 | PF Keep; Cad Cam Keep Block | Clemde S.A. de C.V. | EBI | Class II | |
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer USA Co. Ltd. | FLE | Class II | |
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | DCN | Class II | |
| K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | Medency SRL | NVK | Class II | |
| K231661 | CryoThin™ Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. | GEH | Class II | |
| K231104 | ABPMpro | Somnomedics AG | DSH | Class II | |
| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | Becton Dickinson & Co | GIM | Class II | |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | CAF | Class II | |
| K233160 | NeuTrace EP Mapping System v.2.1 | Anumana Inc. | DQK | Class II | |
| K233525 | MF SC Facial Toning System | Micro Current Technology, Inc. | NFO | Class II | |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | ETD | Class II | |
| K230701 | Stim2Go | Pajunk GmbH Medizintechnologie | IPF | Class II | |
| K230319 | Passio Pump Drainage System | Bearpac Medical, LLC | PNG | Class II | |
| K230311 | HyperSuture | Threadstone LLC | GAT | Class II | |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | |
| K233078 | Posterior Cervical Spine System | Double Medical Technology Inc. | NKG | Class II | |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | Boston Scientific Corporation | GEH | Class II | |
| K232621 | Blood pressure monitor | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Siemens Healthcare Diagnostics Inc. | OYE | Class II | |
| K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | FWP | Class II | |
| K231797 | Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation | QRL | Class II | |
| K231245 | Digital Blood Pressure Monitor (Arm Type) | Guangdong Genial Technology Co., Ltd. | DXN | Class II | |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K230529 | HealiAid Dental Collagen Wound Dressing | Maxigen Biotech, Inc. | OLR | Unclassified | |
| K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | DSA | Class II | |
| K222499 | Disposable Endoscope Valves Kit | Shanghai Seegen Photoelectric Technology Co., Ltd | ODC | Class II | |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & Co. KG | OWN | Class II | |
| K233245 | MagnetOs Flex Matrix | Kuros Biosciences BV | MQV | Class II | |
| K233191 | TotalTi ACDF by SAGICO | Spinal Analytics & Geometrical Implant Co, LLC | OVE | Class II | |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | ODP | Class II | |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | MUH | Class II | |
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator | CS Medical LLC | PSW | Class II | |
| K233010 | Beagank 4T Plus | Belega, Inc. | NFO | Class II | |
| K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II |