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 |
|---|---|---|---|---|---|
| K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | KGN | Unclassified | |
| K221879 | Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 | Caf Medical Solutions Inc | MHX | Class II | |
| K221381 | KDG Abutments | Keystone Dental Inc. | NHA | Class II | |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | JKA | Class II | |
| K220056 | iSyncWave | Imedisync Inc. | GWQ | Class II | |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | ILY | Class II | |
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, Inc. | HQE | Class II | |
| K212364 | BLT Dental Implant System | Bio Concept Co., Ltd. | DZE | Class II | |
| K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC | KLE | Class II | |
| K222083 | LimFlow V-Ceiver | LimFlow Inc. | MMX | Class II | |
| K221789 | IRIS Pi Q switched Nd YAG laser | Bio-Med USA, Inc. | GEX | Class II | |
| K221776 | NextGen Pedicle Screw System | Corelink, LLC | NKB | Class II | |
| K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech Inc. | OLO | Class II | |
| K220077 | IMICRYL Composite, Composite Flow Materials | Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S. | EBF | Class II | |
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S. | EMA | Class II | |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | SRI Trang Gloves (Thailand) Public Company Limited. | LYY | Class I | |
| K222072 | Dolphin Imaging 12.0 | Patterson Dental Supply, Inc. | LLZ | Class II | |
| K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | ELW | Class II | |
| K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | |
| K213727 | dS Sentinelle Breast 16ch 3.0T Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | |
| K213645 | ClearPoint Maestro Brain Model | ClearPoint Neuro Inc. | QIH | Class II | |
| K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K211675 | Dasky Disposable Sampling Tube (Model name: VSM02) | Ningbo Dasky Life Science Co., Ltd. | QBD | Class II | |
| K221854 | Reprocesses Umbilical Cable | Innovative Health, LLC. | NLH | Class II | |
| K213934 | Pro Guard Nitrile Powder Free Examination Glove | Medical Glove Co., Ltd. | LZA | Class I | |
| K221405 | Neurophet SCALE PET | Neurophet, Inc. | LLZ | Class II | |
| K221350 | Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Rubberex Alliance Products Sdn Bhd | LZA | Class I | |
| K221336 | Avéli | Revelle Aesthetics, Inc. | OUP | Class II | |
| K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co.,Ltd. | HIS | Class II | |
| K220045 | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | DK Medivision Co., Ltd. | LPL | Class II | |
| K213993 | Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | Careglove Global Sdn Bhd | LZA | Class I | |
| K213876 | Spineology Navigation Instruments | Spineology, Inc. | OLO | Class II | |
| K213791 | Unispace SA Cervical Cage | Edisoninno Co., Ltd. | OVE | Class II | |
| K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | GAM | Class II | |
| K221953 | Masimo CARESCAPE SpO2 – Masimo with SpHb | Masimo Corporation | DQA | Class II | |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | FUJIFILM Corporation | ODG | Class II | |
| K221628 | exGraft, exGraft Carbon | Peca Labs, Inc. | DSY | Class II | |
| K221328 | Bloomi Smooth Water Based Lubricant | The Bloomi Inc. | NUC | Class II | |
| K221124 | MANTIS Clip | Boston Scientific Corporation | PKL | Class II | |
| K221104 | Actera™ hip system | ConforMIS, Inc. | MEH | Class II | |
| K220887 | Mini-ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) | Well-Life Healthcare Limited | NUH | Class II | |
| K220303 | MDHearingAid app, MDHearingAid Smart hearing aids | Mdhearingaid | QDD | Class II | |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | |
| K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | PBF | Class II | |
| K221432 | Customize | 3D-Side | QIH | Class II | |
| K221347 | Transpara 1.7.2 | Screenpoint Medical | QDQ | Class II | |
| K220139 | QScreen | Path Medical GmbH | GWJ | Class II | |
| K213614 | Cannulated Screws | Maxxion Medical, LLC | HWC | Class II | |
| K213477 | Root ZX3 | J. Morita USA, Inc. | EKZ | Class II |