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 |
|---|---|---|---|---|---|
| K202991 | Fotona XPulse Pro Laser Platform | Fotona d.o.o. | GEX | Class II | |
| K201935 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co.,Ltd | IRP | Class II | |
| K211250 | VisionPort System | New View Surgical, Inc. | GCJ | Class II | |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | KWT | Class II | |
| K210866 | Steri-Dot Process Indicator | Propper Manufacturing Co., Inc. | JOJ | Class II | |
| K210855 | Straumann BLX Implant System | Straumann USA, LLC | DZE | Class II | |
| K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | 7D Surgical, Inc. | OLO | Class II | |
| K210375 | Powder Free Blue Nitrile Examination Glove | Duramitt Sdn Bhd | LZA | Class I | |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | MUE | Class II | |
| K202855 | Orthodontic Facemask | Ita.O Italian Orthodontic System S.r.l. | DZB | Class II | |
| K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green | Shen Wei (USA), Inc. | LZA | Class I | |
| K201737 | Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | Class II | |
| K193301 | coDiagnostiX | Dental Wings GmbH | DZJ | Class II | |
| K210495 | Port Access System | Surgical Innovations Ltd | GCJ | Class II | |
| K210430 | Intravascular Extension Set | Baxter Healthcare Corporation | FPA | Class II | |
| K210220 | Kontact Dental Implant System | Biotech Dental SAS | DZE | Class II | |
| K202964 | iBed Wireless with iBed Mobile | Stryker Corp. | FNL | Class II | |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd | GZJ | Class II | |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | |
| K210886 | MIS Lance+ Conical Connection Dental Implant System | Dentsply Sirona Inc | DZE | Class II | |
| K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | Ambu A/S | EOQ | Class II | |
| K210700 | NaviNetics D1 Stereotactic System | Navinetics Inc | HAW | Class II | |
| K210364 | Migraine Tens Digital Pain Reliever | Shenzhen Dongdixin Technology Co., Ltd. | PCC | Class II | |
| K210281 | Fist Assist Devices Model FA-1 | Fist Assist Devices, LLC | IRP | Class II | |
| K203514 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | |
| K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | MAI | Class II | |
| K202440 | Infrared Thermometer | Shenzhen Sonida Digital Technology Co., Ltd. | FLL | Class II | |
| K201744 | Su2ura Approximation Device | Anchora Medical, Ltd. | OCW | Class II | |
| K201314 | Restor3d Utility Wedge | restor3d, Inc. | PLF | Class II | |
| K211336 | Disposable Vinyl Examination Glove | Inner Mongolia Cureguard Medical Materials Co., Ltd. | LYZ | Class I | |
| K211310 | AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) | Megine Industries Sdn Bhd | LZA | Class I | |
| K211044 | Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics | LIT | Class II | |
| K210920 | iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility LLC | IMK | Class II | |
| K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | LRK | Class II | |
| K210034 | EnsoSleep | Ensodata, Inc. | OLZ | Class II | |
| K203200 | Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co., Ltd. | FXX | Class II | |
| K202718 | Qmenta Care Platform Family | Mint Labs, Inc., D/B/A. Qmenta | LLZ | Class II | |
| K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | MVM | Class II | |
| K211520 | Amerishield Surgical Mask | Premiumestore, LLC | FXX | Class II | |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies | MAX | Class II | |
| K203244 | CellChek 20 rc | Konan Medical, Inc. | NFJ | Class II | |
| K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | Volcano Atheromed, Inc. | MCW | Class II | |
| K211136 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) | bioMerieux, Inc. | LON | Class II | |
| K211101 | E-Temp | Envisiontec GmbH | EBG | Class II | |
| K210814 | Coconu Water Based Personal Lubricant | Coconu, LLC | NUC | Class II | |
| K210518 | Surgical Face Mask | Shandong Haidike Medical Products Co., Ltd | FXX | Class II | |
| K203850 | CATS®-D Tonometer Prism | Cats Tonometer, LLC | HKY | Class II | |
| K203400 | Corrugated tube with mouthpiece accessory | Trudell Medical International | CAF | Class II | |
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies Inc. | FFK | Class II | |
| K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co.,Ltd | CAF | Class II |