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 |
|---|---|---|---|---|---|
| K010557 | Jax Granules Bone Void Filler | Smith & Nephew, Inc. | MQV | Class II | |
| K010554 | Meniscus Arrow Sheath #Cn1000a; Smartscrew Acl Sheath #Ssa2000a | Bionx Implants, Inc. | HWC | Class II | |
| K003505 | Kfa-127 Knee, Foot and Ankle Array | Mri Devices Corp. | MOS | Class II | |
| K011480 | Viva | Richter Rubber Technology Sdn. Bhd. | HIS | Class II | |
| K011418 | Ultraguide Mr-Guide 3000 | Ultraguide, Ltd. | LNH | Class II | |
| K011288 | Tc-Plus Porous Tibial Components | Plus Orthopedics | JWH | Class II | |
| K011258 | Tc-Plus Porous Femoral Components | Plus Orthopedics | JWH | Class II | |
| K011201 | Alpco Milenia Anti-Tpo Elisa | American Laboratory Products Company | JZO | Class II | |
| K011004 | Needlelok Hypodermic Needle Protection | Diasol, Inc | FMI | Class II | |
| K010858 | Velogene Genomic Identification Assay for Mrsa with One-Step Detection | Id Biomedical Corp. | MYI | Class II | |
| K010818 | Infant Limb Holder, Models 306080 & 306081 | Skil-Care Corp. | FMQ | Class I | |
| K010533 | Biosling - Bioabsorbable Polymer Sling & Surgical Mesh | Injectx, Inc. | FTL | Class II | |
| K002848 | Spo2 Wrap Sensor | Epic Medical Equipment Services, Inc. | DQA | Class II | |
| K001971 | Hemodialysis Tubing Sets | Ofi Biomedica S.p.A. | FIB | Class II | |
| K011457 | Aloka Ssd-5500 with Ki and a-Sma | Aloka Co., Ltd. | IYN | Class II | |
| K011324 | Cambridge Heart Model Ch 2000 Cardiac Diagnostic System | Cambridge Heart, Inc. | DQK | Class II | |
| K011246 | Dcm 1.0 | Mds Nordion | MUJ | Class II | |
| K011237 | Lactosorb Plates, Meshes, and Panels/sheets | Zimmer GmbH | HRS | Class II | |
| K011177 | Bci Advisor Vital Signs Monitor (9200) | Bci, Inc. | DPS | Class II | |
| K011089 | Speciality 42 UV (Hefilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Speciality 42 UV Toric (Hefilcon a) Soft C | Specialty Ultravision, Inc. | LPL | Class II | |
| K010877 | Chemwell, Model 2900 | Awareness Technology, Inc. | CIX | Class II | |
| K010809 | Bioconnect Patient Monitoring Cables and Leadwires, Cat# 1000 Thru Cat# 40000 | Rf Industries, Ltd. | DSA | Class II | |
| K010680 | CT Spacer | Clinical Technologies, Inc. | CAF | Class II | |
| K010576 | Monarch Spine System | Depuyacromed | MNI | Class II | |
| K010543 | Km-30 TENS Electrode | Katecho LLC | GXY | Class II | |
| K010525 | Arthrex Tenodesis Screw 7Mm, 8Mm, 9Mm | Arthrex GmbH | HWC | Class II | |
| K010518 | Synthes Anterolateral Calcaneal Plate | Synthes (USA) Products LLC | KTT | Class II | |
| K004049 | Polvue Multifocal (Polymacon) Soft Contact Lens for Daily Wear (Clear and Visibility Tinted, Fully Cast-Molded Lens) | Optech, Inc. | LPL | Class II | |
| K003618 | Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model Bio-1-1014 | Whiteside Biomechanics, Inc. | NDD | Class II | |
| K003251 | Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690 | Blease Medical Equipment, Ltd. | BSZ | Class II | |
| K002831 | Vega Ultrasonic Nebulizer | Vega Technologies Inc. | CAF | Class II | |
| K010787 | Pacing Lead Bipolar Adapters and Extensions | Oscor Inc. | DTD | Class II | |
| K010711 | Ecotract Adjustable Wound Protector/retractor | Advanced Surgical Concepts (Asc) | KKX | Class II | |
| K010580 | Palomar Slp 1000 | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/n 102006, P/n 102007 | Afx, Inc. | NEY | Class II | |
| K003918 | Oscor Permanent Pacing Lead Rz Model Series | Oscor Inc. | DTB | Class III | |
| K003890 | Vhf Ultrasonic Arc-Scan System | Ultralink, LLC | IYO | Class II | |
| K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | DQY | Class II | |
| K003318 | Photon Multi-Platform System, Model Z-12834-X & Z-13175-X | Paradigm Medical Industries, Inc. | GEX | Class II | |
| K003105 | Biosphere Medical Infusion Catheter | Biosphere Medical, S.A. | DQO | Class II | |
| K011028 | Screw-Vent Dental Implant System | Sulzer Dental, Inc. | DZE | Class II | |
| K010936 | Modification to Seamguard Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | OXD | Class II | |
| K010915 | Cdmx | Camsight Co., Inc. | MUH | Class II | |
| K010864 | Analyst Panels + Analytical Test Rotor | Hemagen Diagnostics, Inc. | KHS | Class II | |
| K010834 | Lyra Series Surgical Laser System & Accessories | Laserscope | GEX | Class II | |
| K010728 | Harmone-Schwarzer EEG System | Stellate Systems | OLV | Class II | |
| K010513 | Cardiac View, Model 2001 | Magna-Lab, Inc. | MOS | Class II | |
| K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision ENT | Brainlab, Inc. | HAW | Class II | |
| K003446 | Symmetry Aortic Clip System | St. Jude Medical Cardiovascular Group, Inc. | NCA | Class II | |
| K003395 | Gen-Probe Aptima Combo 2 Assay | Hologic, Inc. | LSL | Class II |