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 |
|---|---|---|---|---|---|
| K221779 | ASEPT Peritoneal Drainage System | PFM Medical GmbH | PNG | Class II | |
| K212579 | FortiShield (Biosynthetic Wound Matrix) | Organogenesis, Inc. | KGN | Unclassified | |
| K230643 | CP620G LCD monitor, CP620 LCD monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K223595 | vPATCH | Virility Medical Ltd. | QRC | Class II | |
| K223182 | Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy | Worldwork S.R.L | OIV | Class II | |
| K222416 | RIA Safeguard | Ria Tech Co., Ltd. | FRF | Class II | |
| K221870 | CarnaLife Holo | Medapp S.A. | LLZ | Class II | |
| K230972 | Ingenia Elition and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K230908 | Hand Trauma Threaded Nail System | Skeletal Dynamics, Inc | HWC | Class II | |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical Inc. | KPS | Class II | |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | OAP | Class II | |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | FZP | Class II | |
| K230058 | Bladeless Trocar – Artemis Lap Cannula | T.A.G. Medical Products Corporation Ltd | GCJ | Class II | |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | OHS | Class II | |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | WONTECH Co., Ltd. | OAP | Class II | |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | Nobel Biocare AB | NHA | Class II | |
| K223634 | Customized Abutment | ARUM DENTISTRY Co., Ltd. | NHA | Class II | |
| K222934 | Nanox.ARC | Nano-X Imaging Ltd | IZF | Class II | |
| K222636 | ET Abutment System | Hiossen, Inc. | NHA | Class II | |
| K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | ODP | Class II | |
| K221390 | BNLE Access Guidewire | Biomerics NLE | DQX | Class II | |
| K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technology | Kurin, Inc. | JKA | Class II | |
| K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | CAW | Class II | |
| K230911 | Braun Skin i.expert | Cyden Limited | OHT | Class II | |
| K230845 | 32Hl512d, 31Hn713d, 32Hq713d | LG Electronics.Inc | PGY | Class II | |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | ConforMIS, Inc. | JWH | Class II | |
| K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | ConMed Corporation | GEI | Class II | |
| K230539 | ArtiSential Laparoscopic Instruments-Electrodes | LivsMed Inc. | GEI | Class II | |
| K230272 | Renuvion® APR Handpiece | Apyx Medical Corporation | GEI | Class II | |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | ELW | Class II | |
| K223734 | ENT Em | Brainlab, Inc. | PGW | Class II | |
| K223520 | UNIDRIVE SIII System | Karl Storz Endoscopy-America, Inc. | HIH | Class II | |
| K223398 | Gastric Alimetry System | Alimetry Ltd | MYE | Class II | |
| K223212 | Precision DL | GE Healthcare | KPS | Class II | |
| K223210 | ClotTriever XL Catheter | Inari Medical, Inc. | QEW | Class II | |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | Terumo Cardiovascular Systems Corporation | NTE | Class II | |
| K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Stryker Corp. | HRS | Class II | |
| K222352 | Epildream HP 4000 MED | D.E.A Project S.R.1. | GEX | Class II | |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color | Guangdong Kingfa Sci.&tech.co.,Ltd. | LZA | Class I | |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience | GWQ | Class II | |
| K213078 | Myolift QT | Johari Digital Healthcare, Ltd. | NFO | Class II | |
| K230829 | TENS7000 Rechargeable (Model:TENS7000 Rechargeable) | Chongqing Rob Linka Science and Technology Co., Ltd. | NUH | Class II | |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | MXD | Class II | |
| K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | LLZ | Class II | |
| K230499 | ArtiSential Laparoscopic Instruments-Electrodes | LivsMed Inc. | GEI | Class II | |
| K223932 | SafeAir combi (SFR-combi-US) | LiNA Medical Inc | GEI | Class II | |
| K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | MAX | Class II | |
| K222996 | Access PCT | Siemens Healthcare Diagnostics Inc. | PTF | Class II | |
| K222584 | Evis X1 Video System Center Olympus Cv-1500, Colonovideoscope Olympus Cf-Hq1100dl/i, Gastrointestinal Videoscope Olympus Gif-1100 | Olympus Medical Systems Corp. | FET | Class II | |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | EKX | Class I |