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 |
|---|---|---|---|---|---|
| K213851 | Disposable Medical Nitrile gloves | Guangdong Xingcan Brothers Medical Technology Co.,Ltd | LZA | Class I | |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | GWF | Class II | |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | L&K Biomed Co.,Ltd. | MAX | Class II | |
| K212499 | BD Insulin Syringe (0.3mL) | Becton Dickinson & Co | FMF | Class II | |
| K211780 | ZEN-2090 Turbo | Genoray Co., Ltd. | OWB | Class II | |
| K211155 | Auto CPAP System | BMC Medical Co., Ltd. | BZD | Class II | |
| K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | Medos International SARL | NKB | Class II | |
| K214087 | Medical Face Mask | Hubei Medlink Healthcare Co., Ltd. | FXX | Class II | |
| K213741 | TENS & EMS DEVICE (Model: FM-B2403A) | Shenzhen Jian Feng Electronic Technology Co., Ltd | NUH | Class II | |
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | ONF | Class II | |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | KTI | Class II | |
| K212049 | Oclet TDS 1000 | TendoNova Corporation | LFL | Unclassified | |
| K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 | Stryker Sustainability Solutions | DQA | Class II | |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) | Stryker Sustainability Solutions | NLF | Class II | |
| K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K220506 | SkinPen Precision System | Crown Aesthetics | QAI | Class II | |
| K220450 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K211639 | Btl-785W | BTL Industries, Inc | GEI | Class II | |
| K220327 | geko W-3 | Firstkind Ltd | IPF | Class II | |
| K220051 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K213994 | Flexible Block | Shandong Huge Dental Material Corporation | EBI | Class II | |
| K213703 | Surgical Gown | Wujiang Tutaike Textiles & Finishing Co., Ltd. | FYA | Class II | |
| K213358 | Surgical Mask | Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FXX | Class II | |
| K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | IZL | Class II | |
| K212723 | BTL-995-rTMS | BTL Industries, Inc | OBP | Class II | |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | KWS | Class II | |
| K212281 | Surgical Trays | Dentsply Sirona Inc | KCT | Class II | |
| K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat | Kinetic Innovative Seating System, LLC | KNN | Class I | |
| K211900 | Patient Information Center iX | Philips Medizin Systeme Boblingen GmbH | MHX | Class II | |
| K211843 | PolyLock Plating System | Fusion Orthopedics, LLC | HRS | Class II | |
| K211808 | Medcare Powder-Free Blue Nitrile Patient Examination Gloves | Dongguan Grinvald Technology Co., Ltd. | LZA | Class I | |
| K210365 | Second Opinion | Pearl, Inc. | MYN | Class II | |
| K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | WRP Asia Pacific Sdn Bhd | LZA | Class I | |
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | Shantou Wealy Medical Instrument Co., Ltd. | MEG | Class II | |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | LYC | Class II | |
| K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | Medynus, Inc. | KWQ | Class II | |
| K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation | LNH | Class II | |
| K213835 | TENS & EMS Device | Shenzhen Jian Feng Electronic Technology Co., Ltd | NUH | Class II | |
| K213778 | IV Administration Set | B.Braun Medical, Inc. | FPA | Class II | |
| K213671 | Astroglide Sensual Strawberry Personal Lubricant | Biofilm, Inc. | NUC | Class II | |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K213285 | easy Claire | Y&j Bio Co., Ltd. | OHS | Class II | |
| K212720 | nordicDSC | NordicNeuroLab AS | LLZ | Class II | |
| K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | NHA | Class II | |
| K212149 | MyndMove 2.0 | Myndtec Inc | GZI | Class II | |
| K211850 | Air Compression Leg Massager (model: FE-7204B) | Xiamen Healthpal Electronic Co,.ltd. | IRP | Class II | |
| K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers | Wuxi Beien Surgery Device Co., Ltd. | GDW | Class II | |
| K211787 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | |
| K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T | NORAS MRI products GmbH | MOS | Class II | |
| K220006 | angioLOCK Polymer Ligating Clip | A2 Medical Systems, LLC | FZP | Class II |