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 |
|---|---|---|---|---|---|
| K220579 | Hybrid C70 | Digimed Co., Ltd | EHD | Class II | |
| K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | ArthroCare Corporation | GEI | Class II | |
| K220531 | Fox 810, Fox 980 | A.R.C. Laser GmbH | GEX | Class II | |
| K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K | Magnus Medical Inc. | OBP | Class II | |
| K220104 | Knee+ | Pixee Medical | SBF | Class II | |
| K201876 | Soteria Bed Barrier | Trinity Guardion, Inc. | QTV | Class I | |
| K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K222325 | 8ch Wrist Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | |
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. dba Realcloud Imaging | MUH | Class II | |
| K221745 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | Class II | |
| K221635 | IPL sapphire ice cooling hair remove device | Shenzhen Desida Technology Co., Ltd. | OHT | Class II | |
| K221541 | LimFlow ARC | LimFlow Inc. | PDU | Class II | |
| K221507 | Disposable Blood Lancet | Sterilance Medical (Suzhou) Inc. | QRK | Class II | |
| K221475 | MyClearALIGN Dental Aligner System | Key Dental Technologies, LLC | NXC | Class II | |
| K221467 | INHANCETM Reverse Glenoid Peripheral Posts | Depuy Ireland UC | PHX | Class II | |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | Kerr Corporation | EBF | Class II | |
| K221040 | Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) | Jiangxi Aicare Medical Technology Co., Ltd | DXN | Class II | |
| K220933 | QT Scanner 2000 Model A | QT Imaging, Inc. | IYO | Class II | |
| K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | I.T.S. GmbH | HRS | Class II | |
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | PBK | Class II | |
| K221999 | Ultrasound Transmission Gels | Hony Medical Co., Ltd | MUI | Class II | |
| K221970 | Lancing device | Sterilance Medical (Suzhou) Inc. | QRL | Class II | |
| K221871 | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx | Healstone Biotech Inc. | NFT | Class II | |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | Brainlab, Inc. | OLO | Class II | |
| K221486 | Index Bpm | Ya Horng Electronic Co., Ltd. | DXN | Class II | |
| K221164 | Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl | Hong Seng Gloves Sdn Bhd | LZA | Class I | |
| K221157 | JR Medic | JR Engineering and Medical Technologies (M) Sdn Bhd | LZC | Class I | |
| K220618 | SaliPen | Saliwell Ltd. | QTT | Class II | |
| K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | DRB | Class II | |
| K220067 | Medical Surgery Mask, Model:2626-7 | Dongguan Missadola Technology Co., Ltd. | FXX | Class II | |
| K214118 | Riva Cem Automix | Sdi Ltd. | EMA | Class II | |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | JKA | Class II | |
| K212846 | Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use | Jiangsu Jichun Medical Devices Co., Ltd. | FMF | Class II | |
| K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | FRN | Class II | |
| K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | PHC | Class II | |
| K222362 | Salvo® Spine System | Spine Wave Inc | NKB | Class II | |
| K222279 | Rusch Intermittent Urethral Catheters | Teleflex Medical | EZC | Class II | |
| K221785 | TCL3 Motion Tracking System | TracInnovations A/S | LNH | Class II | |
| K221189 | Oliz Ltb-1000A | Ltbio Co., Ltd. | ILY | Class II | |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corp. | HKI | Class II | |
| K221100 | Viz RV/LV | Viz. Ai, Inc. | QIH | Class II | |
| K220799 | K-SHIELD Zen | Sb-Kawasumi Laboratories, Inc. | JKA | Class II | |
| K220676 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K212370 | Leaderflex Mini and Leaderflex Nano | Vygon U.S.A. | FOZ | Class II | |
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | HMD Biomedical, Inc. | NBW | Class II | |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | Better Care Plastic Technology Co., Ltd. | LZC | Class I | |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Corentec Co., Ltd. | JWH | Class II | |
| K222277 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K222263 | Arthrex Self Punching SwiveLock Suture Anchors | Arthrex GmbH | MAI | Class II |