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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K223752 | Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl | Central Medicare Sdn Bhd | LZA | Class I | |
| K223347 | UltraSight AI Guidance | Ultrasight | QJU | Class II | |
| K223322 | Argus Cognitive ReVISION Software | Argus Cognitive, Inc. | LLZ | Class II | |
| K230931 | Atlan | Drägerwerk AG Co. KGaA | BSZ | Class II | |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent Inc | PGW | Class II | |
| K231861 | EndoflipTM 300 System | Medtronic, Inc. | FFX | Class II | |
| K231848 | Triever20 Curve (21-201) | Inari Medical, Inc. | QEW | Class II | |
| K231516 | INHANCE™ Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | MBF | Class II | |
| K231483 | MySpine Unilateral Guides | Medacta International SA | PQC | Class II | |
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | OLI | Class II | |
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple Inc. | QDB | Class II | |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe | Becton Dickinson & Co | NGT | Class II | |
| K231021 | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Kimberly-Clark Corporation | LZA | Class I | |
| K230560 | enspire 300 Series Automated Endoscope Reprocessor System | STERIS Corporation | NZA | Class II | |
| K230150 | OptimMRI | Rebrain, SAS | QIH | Class II | |
| K223769 | NextAR™ Spine Platform | Medacta International SA | SBF | Class II | |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics GmbH | NBC | Class II | |
| K223499 | Three Way Stop Cock | M/S Romsons International | FMG | Class II | |
| K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | CJE | Class II | |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | ConforMIS, Inc. | MBH | Class II | |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab, Inc. | HAW | Class II | |
| K223189 | Firefighter™ NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd | LOX | Class II | |
| K223037 | Infrared Thermometer, Model: IR8807 | Shen Zhen Rong Feng Technology Co., Ltd. | FLL | Class II | |
| K221327 | BD Alaris™ Pump Infusion Sets | Care Fusion | FPA | Class II | |
| K221319 | BD Alaris™ Pump Epidural Infusion Set | Care Fusion | PWH | Class II | |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | CareFusion 303, Inc | FRN | Class II | |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | Boston Scientific Corporation | GEX | Class II | |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | L&K Biomed Co.,Ltd. | NKG | Class II | |
| K231808 | QUASAR Standalone ACIF System | GS Medical Co., Ltd. | OVE | Class II | |
| K231799 | INERTIA® CONNEXX™ Modular Pedicle Screw System | Nexxt Spine LLC | NKB | Class II | |
| K231790 | The InMode System with the Morpheus8 Applicators | Inmode Ltd. | GEI | Class II | |
| K231103 | ROSA ONE Brain Application | MedTech SAS | HAW | Class II | |
| K230875 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | Central Medicare Sdn Bhd | LZA | Class I | |
| K230787 | Oscar 15 & Oscar 15i | Genoray Co., Ltd. | OWB | Class II | |
| K230377 | CROSSLEAD Penetration Peripheral Guide Wire | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K230039 | uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | |
| K223834 | AccuCheck | Manteia Technologies Co.,Ltd. | IYE | Class II | |
| K223484 | IGAR System (1001.A) | Insight Medbotics, Inc. | MOS | Class II | |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System | Spinecraft LLC | OLO | Class II | |
| K222920 | Oxygen concentrator | Zhengzhou Olive Electronic Technology Co., Ltd. | CAW | Class II | |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | JGS | Class II | |
| K213098 | Panther 5 | Origin Medical Devices Inc | CBK | Class II | |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K Biomed Co.,Ltd. | KWQ | Class II | |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | Vatech Co., Ltd. | OAS | Class II | |
| K231472 | Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) | Suzhou Sweetrich Vehicle Industry Technology Co,Ltd. | INI | Class II | |
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | LZY | Class II | |
| K231437 | Lf900 | Daesung Maref Co.,Ltd | IRP | Class II | |
| K231410 | RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies LLC | FIP | Class II | |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System | Bonebridge AG | HRS | Class II | |
| K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | OEB | Class II |