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 |
|---|---|---|---|---|---|
| K211542 | Primo S | A.T.S. Applicazione Tecnologie Speciali S.r.l. | MQB | Class II | |
| K211493 | Monarch Platform | Auris Health, Inc | EOQ | Class II | |
| K211107 | Btl-899 Fp | BTL Industries, Inc | GEI | Class II | |
| K211088 | Grosz Play Feel | Rb Health (Us), LLC | NUC | Class II | |
| K210821 | Medical PVC Examination Gloves | Jiangxi Hongda Medical Equipment Group Ltd. | LYZ | Class I | |
| K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | LOD | Class II | |
| K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | MJN | Class II | |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical Ltd | LOX | Class II | |
| K202517 | Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | QAI | Class II | |
| K201675 | VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K201262 | Microwave Therapeutic System | Nanjing Eco Microwave System Co., Ltd. | NEY | Class II | |
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | Gx Corporation Sdn Bhd | KGO | Class I | |
| K200575 | Truemed Hand, Foot and Ankle Plates System | Truemed Group, LLC | HRS | Class II | |
| K211788 | Halo | Nicolab B.V. | QAS | Class II | |
| K211480 | NubeX | Techheim Co., Ltd. | LLZ | Class II | |
| K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | DQK | Class II | |
| K211442 | StealthStation Spinous Process Clamps | Medtronic Navigation, Inc | OLO | Class II | |
| K211094 | Nerve and Muscle Stimulator | Shenzhen XFT Medical Limited | IPF | Class II | |
| K211052 | Straumann RidgeFit Implants | Straumann USA, LLC | DZE | Class II | |
| K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | KLE | Class II | |
| K210380 | Medical surgical mask | Shantou T&K Medical Equipment Factory Co.,Ltd | FXX | Class II | |
| K210267 | Disposable Surgical Mask | Xiamen Eagledon Pharmaceutical Co., Ltd. | FXX | Class II | |
| K210104 | SurroundScope System | 270SURGICAL | HET | Class II | |
| K203659 | iSR'obot Mona Lisa 1.0 | Biobot Surgical Pte. Ltd. | IYO | Class II | |
| K203158 | BioWave BioWraps | Biowave Corporation | GXY | Class II | |
| K203148 | Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | HGX | Class II | |
| K202922 | END 200 Endoscopic Tubeset | Palliare | FCX | Class II | |
| K202579 | TruAbutment DS, TruBase | TruAbutment Inc. | NHA | Class II | |
| K201835 | Pre-Sure | Lazarus 3D, Inc. | LLZ | Class II | |
| K193490 | SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. | LLH | Class I | |
| K192971 | Nebulizer Kit | Excellentcare Medical (Huizhou) Ltd. | CAF | Class II | |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc | LNH | Class II | |
| K211002 | Grappler Suture Anchor System | Paragon 28 | MBI | Class II | |
| K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | LLZ | Class II | |
| K210524 | Surgical Mask | Changzhou Holymed Products Co., Ltd | FXX | Class II | |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K210215 | Surgical Gowns | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | FYA | Class II | |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG | Class II | |
| K203003 | Pantheon IBFD | Pantheon Spinal LLC | MAX | Class II | |
| K202741 | Infrared Forehead Thermometer | Shenzhen Combei Technology Co.,Ltd. | FLL | Class II | |
| K201740 | Hydrozid | Medilink A/S | GEH | Class II | |
| K201726 | Arterial Catheter | Haolang Medical USA Corporation | DQY | Class II | |
| K211821 | DEKA Motus AZ | El.en. Electronic Engineering SpA | GEX | Class II | |
| K210480 | AcuPebble SA | Acurable Limited | MNR | Class II | |
| K203459 | SafeCross Transseptal Puncture and Introducer (TSP/I) System | East End Medical I, LLC | DYB | Class II | |
| K203309 | NUVO CF Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K203198 | KARL STORZ Metal Sterilization Trays | Karl Storz Endoscopy-America, Inc. | KCT | Class II | |
| K193622 | TRIOCLEAR System | Perfection Aligner System Hong Kong Limited | NXC | Class II | |
| K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown | Jiangsu Medplus Non-woven Manufacturer Co.,Ltd. | FYA | Class II |