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 |
|---|---|---|---|---|---|
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | JTN | Class II | |
| K260805 | Dual Core | Vericom Co., Ltd. | EBF | Class II | |
| K260196 | ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & Co. KG | GCJ | Class II | |
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | QJP | Class II | |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | Verathon Medical (Canada) ULC | FAJ | Class II | |
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni | MYN | Class II | |
| K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation SAS | OLO | Class II | |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | Shenzhen Imdk Medical Technology Co., Ltd. | DQA | Class II | |
| K250964 | Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | JCX | Class II | |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics LLC | HRS | Class II | |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system | Carlsmed, Inc. | MAX | Class II | |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | IYE | Class II | |
| K260788 | Smylio Aligners | Smylio | NXC | Class II | |
| K260419 | LingOral Dental Design System | Hangzhou Chohotech Co., Ltd | PNN | Class II | |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | LLZ | Class II | |
| K254215 | Arthrex Beaming System | Arthrex GmbH | HWC | Class II | |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix SRL | HSB | Class II | |
| K253679 | Hydro Irrigation System | Stryker Corp. | GWG | Class II | |
| K253396 | AYON Body Contouring System™ (AYON SYSTEM) | Apyx Medical Corporation | QPB | Class II | |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | GXY | Class II | |
| K253013 | Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co.,Ltd | GCA | Class II | |
| K252621 | DeepSkin (DEP100) | El Global Trade Ltd. | NFO | Class II | |
| K252617 | MiroCam® Capsule Endoscope System | IntroMedic Co., Ltd. | NEZ | Class II | |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | Zeus Scientific LLC | OBE | Class II | |
| DEN250013 | Modius Spero | Neurovalens | SHX | Class II | |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co.,Ltd. | GEX | Class II | |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Straumann USA, LLC | NHA | Class II | |
| K254276 | Lynx Aspiration Catheter System | Q'apel Medical, Inc. | NRY | Class II | |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | GXY | Class II | |
| K253992 | Veritas Reverse Total Shoulder System | restor3d, Inc. | PHX | Class II | |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | OBO | Class II | |
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle | Galvanize Therapeutics | OAB | Class II | |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System | Globus Medical, Inc. | NKB | Class II | |
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & Co. KGaA | CBK | Class II | |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K Biomed Co.,Ltd. | KWQ | Class II | |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical | GAT | Class II | |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corp. | DXQ | Class II | |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | EBI | Class II | |
| K253855 | KardiaPSI Balloon Catheter | Intervention Tech, Inc.; dba Corvention | OZT | Class II | |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | DXN | Class II | |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | MBI | Class II | |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | Shenzhen Changkun Technology Co., Ltd. | KPI | Class II | |
| K261132 | Healium Intelliscan LX192LC | Healium Intelliscan Corporation | IYN | Class II | |
| K261130 | AccelFix Spinal Fixation System | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International SA | OVD | Class II | |
| K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) | Wenzhou Lingfeng Electronic Technology Co., Ltd | IRP | Class II | |
| K252558 | Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II |