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 |
|---|---|---|---|---|---|
| K013075 | Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K012881 | C3 Anterior Cervical Plate System | Spine Vision, Inc. | KWQ | Class II | |
| K011192 | Compressible Limb Sleeve | Alliance Medical Corp. | JOW | Class II | |
| K013565 | Cardiac Diagnostic System, Model Ch2000 | Cambridge Heart, Inc. | DPS | Class II | |
| K013564 | Modification to Heartwave Alternans Processing System, Model Aps | Cambridge Heart, Inc. | DPS | Class II | |
| K013546 | Modification to: 1.5 Bone Fixation Kit, Models Bxs6114, Bxs6214 | Bionx Implants, Inc. | HWC | Class II | |
| K013083 | Carto Xp Ep Navigation System | Biosense Webster Inc | DQK | Class II | |
| K012877 | High Gold Palladium Free Ceramic Solder | Ivoclar USA, Inc. | EJT | Class II | |
| K012854 | Renal Guiding Sheath | Terumo Medical Corp. | DYB | Class II | |
| K011487 | Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model Crps | Somanetics Corp. | DXZ | Class II | |
| K011328 | Cardio Care EKG-2000 12-Channel Electrocardiograph | Bionet Co., Ltd. | LOS | ||
| K010596 | Rusch Bronchus Blocker Kit | Rusch Intl. | CBI | Class II | |
| K010579 | Stent Support Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K013782 | Disetronic Penfine Insulin Injection Pen Needle | Disetronic Medical Systems | FMI | Class II | |
| K013631 | Efilm Video | Efilm Medical, Inc. | LMA | Class II | |
| K013602 | Hnc-63-Int Neurovascular Array Coil | Mri Devices Corp. | MOS | Class II | |
| K013566 | Immulite Intact Pth, Immulite 2000 Intact Pth, Models Lkpp1 (100 Tests), Lkpp5 (500 Tests), L2kpp2 (200 Tests), L2kpp6 | Siemens Healthcare Diagnostics Inc. | CEW | Class II | |
| K013550 | Clirans E-Series Dialyzer | Terumo Medical Corp. | KDI | Class II | |
| K013540 | Ebi Xfix Access Pelvic Fixator | Ebi, LLC | KTT | Class II | |
| K013508 | Hrh-127-Allegra Head Array Coil | Mri Devices Corp. | MOS | Class II | |
| K013469 | Eye-Q (Xylofilcon a) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear | Soflex Contact Lens Industries, Ltd. | LPL | Class II | |
| K013467 | Toric Eye-Q (Xylofilcon a) Soft (Hydrophilic) Toric Multifocal Contact Lens for Daily Wear | Soflex Contact Lens Industries, Ltd. | LPL | Class II | |
| K013368 | Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate | Trek Diagnostic Systems, Ltd. | LTT | Class II | |
| K013332 | Linical Protein I Calibration Verifiers Levels A=e for Beckman Coulter Immage | Cliniqa Corporation | JJY | Class I | |
| K013265 | Validate Chem 7 Calibration Verification Test Set, Model 10007 | Maine Standards Co. | JJY | Class I | |
| K013239 | Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles | Med Gen, Inc. | FMQ | Class I | |
| K013232 | Cybercases by Bausch & Lomb | Bausch & Lomb Incorporated | LRX | Class II | |
| K013220 | Hd/hdt, Pv/pvt (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) | Poly Vue Technolgies, Inc. | LPL | Class II | |
| K013081 | Medstar 150 | Mednet Services, Inc. | IPF | Class II | |
| K013068 | Bioscanner 2000 | Polymer Technology Systems | CGA | Class II | |
| K012944 | Power Drive | Mediteam AB | EKX | Class I | |
| K012910 | The Bioplate Mandible Fixation System | Bioplate Inc | JEY | Class II | |
| K012875 | Signa Openspeed Magnetic Resonance System | GE Healthcare | LNH | Class II | |
| K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | HWC | Class II | |
| K012846 | Zippy, Model I88wa | Pillar Technology, Inc. | ITI | Class II | |
| K012841 | Duo Pal 6, Order-No.: 2154 | Wieland Edelmetalle GmbH & Co. | EJS | Class II | |
| K012830 | Lerman & Son Cranial Orthosis Helmet | Lerman & Son | MVA | Class II | |
| K012818 | Helical Compression Anchor System, Cannulated Single Helix | Triage Medical, Inc. | HWC | Class II | |
| K012817 | Helical Compression Anchor System, Non-Cannulated | Triage Medical, Inc. | HWC | Class II | |
| K012164 | 'Rapidone'-Methadone Test | American Bio Medica Corp. | DJR | Class II | |
| K011963 | Advia 1650 Glucose Hexokinase 11 Assay | Bayer Corp. | CFR | Class II | |
| K011561 | Sereine Extra Strength Daily Cleaner | Wilsa, Inc. | LPN | Class II | |
| K001879 | Infusion IV Set | Nirvi Intl. USA | LRS | Class II | |
| K013491 | Hsg Catheter Set, 5F Model Rgs0947, Hsg Catheter Set, 7F, Model R65-948 | A & A Medical, Inc. | LKF | Class II | |
| K013437 | Sf Sh Catheter, Model R65-945 | A & A Medical, Inc. | LKF | Class II | |
| K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | DZE | Class II | |
| K012929 | Flexible Pediatric Cystoureteroscope, Model Aur- 735 | Circon Video | FAJ | Class II | |
| K012873 | Documenting Laser Slit Lamp, Dp 2010 | Bausch & Lomb Incorporated | HJO | Class II | |
| K012850 | Recording and Stimulating Electrode | Radionics, A Division of Tyco Healthcare Group LP | GZL | Class II | |
| K012806 | Cynosure Photogenica Vl | Cynosure, LLC | GEX | Class II |