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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K100989 | Zura Tee System with Claritee Probe | IMACOR, Inc | IYN | Class II | |
| K100931 | Mylabtwice, Model 6200 | Esaote S.p.A. | IYN | Class II | |
| K100884 | Stryker Knifelight | Howmedica Osteonics Corp | FTD | Class II | |
| K100707 | Reprocessed Pins | Sterilmed Inc | NDM | Class II | |
| K100694 | Colored Powder Free and Polymer Coated Examination Glove (Blue, Black and Pink) with a Protein Claim of Less Than | Tekmedic (M) Sdn Bhd | LYY | Class I | |
| K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | GXH | Class II | |
| K100399 | 4 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim IV, Wl-2504A | Well-Life Healthcare Limited | GZJ | Class II | |
| K100214 | Cornerstone Psr Cervical Interbody Fusion Device | Medtronic Sofamor Danek | ODP | Class II | |
| K100045 | Octo | Dalim Surgnet Corporation | GCJ | Class II | |
| K100001 | Mobivision | Almana Medical Imaging | MQB | Class II | |
| K093196 | Biomesh Ca.b.s. 'Air Composite, Models: Cabst1r05t, Cabsairc7, Cabsairc09 | Cousin Biotech SAS | FTL | Class II | |
| K093104 | Medyssey Co., Ltd., Zenius Spinal System | Medyssey Co., Ltd. | MNI | Class II | |
| K092889 | Syntec Osteo-Plate and Screw Fixation | Syntec Scientific Corp. | HRS | Class II | |
| K092233 | Surgimesh Xd | Aspide Medical | FTL | Class II | |
| K091849 | Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set | Immunodiagnostic Systems Ltd. | MRG | Class II | |
| K091327 | Alden Hp 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden Hp 54 Multifocal &Hp 54 Toric Multifocal Contact Lenses | Alden Optical Labs., Inc. | LPL | Class II | |
| K083878 | Lupotek Correctin Vl, Lupotek Detectin Vl, Plasmacon La | R2 Diagnostics, Inc. | GIR | Class I | |
| K101461 | Bd Directigen Ex Flu A+b | Becton Dickinson & Co | PSZ | Class II | |
| K101320 | Vasovapor | Lexion Medical, LLC. | HIF | Class II | |
| K100902 | Aedis(tm) | Embed Technology, LLC | DZE | Class II | |
| K100665 | Marromax B One Marrow Aspiration Needle Kit, Models 50083-Xx, 50084-Xx | Needle Tech Products, Inc. | FMF | Class II | |
| K100542 | Consensus Revision Knee System | Consensus Orthopedics, Inc. | JWH | Class II | |
| K100359 | Darco Headed Cannulated Screw | Wrightmedicaltechnologyinc | HWC | Class II | |
| K093662 | Echobright | Life-Tech, Inc. | CAZ | Class II | |
| K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | Nobel Biocare AB | NHA | Class II | |
| K093357 | Diamond Medica Ise Module Calibrant a Model Me-6370D, Diamond Medica Ise Module Calibrant B, Model Me-5410D | DIAMOND DIAGNOSTICS Inc | JIT | Class II | |
| K093159 | Pr Cream | Prugen IP Holdings, Inc. | FRO | Unclassified | |
| K093156 | Pruclair Nonsteroidal Cream | Prugen IP Holdings, Inc. | FRO | Unclassified | |
| K092917 | Stern's S250 Nordam | Cefla S.C. | EIA | Class I | |
| K101546 | Endoform Dental Template | Mesynthes, Ltd. | KGN | Unclassified | |
| K101492 | 8 Channel Cardiac Phased Array Coil | GE Healthcare Coils (USA Instruments, Inc.) | MOS | Class II | |
| K101481 | Biomers Translucent Orthodontic Bracket | Biomers Products, LLC | NJM | Class II | |
| K101228 | Mirada Xd | Mirada Medical Limited | LLZ | Class II | |
| K101227 | Back-Tek | York Biomedical, Inc. | ILY | Class II | |
| K101217 | Mac-Mobile Aquatic Chair | Rehamed Intl., LLC | IOR | Class I | |
| K101116 | Hi-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Whisper Ls and Ms Guide Wire with | Abbott Vascular-Cardiac Therapies | DQX | Class II | |
| K101063 | Sleeve with Ziploop Fixation Devices | Biomet Sports Medicine | MBI | Class II | |
| K100798 | Medrad Intego Pet Infusion System, Source Administration Set, Patient Adminstratin Set Model Int Sys 100, Int Css, Int C | Medrad, Inc. | FRN | Class II | |
| K100773 | Kai Spot Model Kms 200 | Kai Medical, Inc. | BZQ | Class II | |
| K100652 | Acl Tightrope | Arthrex GmbH | HTY | Class II | |
| K100438 | Polaris Spinal System, Polaris/synergy Structure Anterior Fixation System | Ebi, LLC | NKB | Class II | |
| K100409 | Polaris Spinal System, Polaris/synergy Structue Anterior Fixation System | Biomet Spine (Aka Ebi, LLC) | NKB | Class II | |
| K100403 | Masimo Rainbow Set Pronto -7 Pulse Co- Oximeter and Accessories, Model Pronto-7 | Masimo Corporation | DQA | Class II | |
| K093707 | Dyna Locking Trochanteric Nail, Model Ng0820 | CG MedTech Co., Ltd. | HSB | Class II | |
| K093319 | Nuvasive Vuepoint Oct System | NuVasive Inc | KWP | Class II | |
| K093197 | Coronis Fusion 10Mp, Model Mdcg-10130 | Barco N.V. | LLZ | Class II | |
| K093078 | Unity Ultrasonic System with Plla Anchors | Bonutti Research, Inc. | HWC | Class II | |
| K092915 | Cedara Webaccess, Model: 2.4 | Cedara Software Corp. | LLZ | Class II | |
| K092781 | Mam Twister | Mam International AG | KKO | Class II | |
| K091912 | B-Genin and R-Genin | Berkeley Advanced Biomaterials | MQV | Class II |