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 |
|---|---|---|---|---|---|
| K033907 | Bd Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole 0.5/9.5 - 16/304 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K033397 | Avita Bpm6 Series Blood Pressure Meter (or Monitor), Model Bpm6xy | Avita Corporation | DXN | Class II | |
| K033362 | Bd Phoenix Automated Microbiology System- Cefuroxime Gram Negative | Becton Dickinson & Co | LON | Class II | |
| K040763 | Resect Medical Inline Bi-Polar RF Linear Coagulation Device | Resect Medical, Inc. | GEI | Class II | |
| K040706 | Gel Mark IV | Senorx, Inc. | NEU | Class II | |
| K040692 | Olympus Hdl Cholesterol Reagent, Osr6195/osr6295 and Olympus Hdl Cholesterol Calibrator Odc0023 | OLYMPUS Corporation of the Americas | JIT | Class II | |
| K040644 | Modification to Depuy Ceramic Femoral Head | Depuy Orthopaedics Inc. | LZO | Class II | |
| K040339 | Brachytherapy Strand Device | Bebig Isotopen-Und Medizintechnik GmbH | KXK | Class II | |
| K040253 | Easy Med Tn-28 C | Easy Med Instrument Co., Ltd. | GZJ | Class II | |
| K040168 | Modification to Geo Structure | Interpore Cross Intl. | MQP | Class II | |
| K040133 | Urine Amphetamine/methamphetamine Screen Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | DKZ | Class II | |
| K040074 | Oneview Interface | NxStage Medical Inc | FKP | Class II | |
| K040061 | Medtronic Minimed Mmt-407C Ambulatory Infusion Pump, Model Mmt-407C | Medtronic, Inc. | FRN | Class II | |
| K033770 | Isoaid Advantage Pd-103, Model Iapd-103A | Isoaid, L.L.C. | KXK | Class II | |
| K033157 | Tanita Segmental Body Composition Analyzer, Model Bc-418 | Tanita Corp. of America | MNW | Class II | |
| K032734 | Convatec Fecal Management System | Convatec, A Bristol-Myers Squibb Co. | KNT | Class II | |
| K040784 | Protab ECG Tabb Electrode | Bio Protech, Inc. | DRX | Class II | |
| K040769 | Structur 2 Sc | Voco GmbH | EBG | Class II | |
| K040752 | Dosi-Fuser | Leventon, S.A. | MEB | Class II | |
| K040698 | Masterscreen Cpx and Oxycon Cpx | Viasys Healthcare GmbH | BZC | Class II | |
| K040667 | Xpert Biliary Stent, Models Ex8l6006, Ex8l3008, Ex8l4008, Ex8l6008, Ex8s6006, Ex8s3008, Ex8s4008, Ex8s6008 | Abbott Medical | FGE | Class II | |
| K040643 | Branemark Integration Dental Implant and Accessories | Branemark Integration AB | DZE | Class II | |
| K040619 | Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plates | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K040614 | Bluewand LED Dental Curing Wand System | J.L. Blosser, Inc. | EBZ | Class II | |
| K040569 | Permanent Pacing Lead, Model Refino, Model: Refino-R, Ru, Rju | Oscor Inc. | DTB | Class III | |
| K040556 | Trophypan C with Orthoimaging/omsimaging Accessory | Eastman Kodak Company | EHD | Class II | |
| K040385 | Multiport Manifold Set with Swabable Valves, Model 9900 | Quest Medical, Inc | FPA | Class II | |
| K040367 | Medpulse Respiratory Vest System, Model 2000Ez | Electromed, Inc. | BYI | Class II | |
| K040195 | Calysto Image IV-Image and Information Management System | Invivo Corporation | LLZ | Class II | |
| K040172 | Modification to Ge Discovery Ls System | GE Healthcare | KPS | Class II | |
| K040105 | Yue Pfong Safety Syringe (3Ml) | Yue Pfong International Industrial Co., Ltd. | MEG | Class II | |
| K040084 | Lifestyle Circulatory Enhancer | Advanced Circulatory Systems, Inc. | BWF | Class II | |
| K040055 | Polylase Lp | DDC Technologies, Inc. | GEX | Class II | |
| K033925 | Biofree | Dental Components, Inc. | EIA | Class I | |
| K033866 | Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits) | Lin-Zhi International Inc | DIO | Class II | |
| K033017 | Phoenix Infusion Catheter | Phoenix Biomedical Corp. | JXG | Class II | |
| K040313 | Hrv Tools | GE Healthcare | DPS | Class II | |
| K040224 | Cadimplant | Praxim S.A | JAK | Class II | |
| K040127 | Cook Ureteral Balloon Dilation Catheter Set | Cook Incorporated | EZN | Class II | |
| K023064 | Hemoclean | Krd Co., Ltd. | NII | Class II | |
| K040772 | Pacific Recumbent Height-Adjustable Bath System | Penner Manufacturing, Inc. | ILJ | Class II | |
| K040164 | K-Y Brand Warming Jelly Personal Lubricant | Personal Products Company, Div. of Mcneil-Ppc, Inc. | NUC | Class II | |
| K040111 | Zeus Scientific, Inc., Athena Multi-Lyte Mpo/pr3 Igg Test System | Zeus Scientific LLC | MOB | Class II | |
| K040029 | Safetynet Guidewire Introducer | Injectimed, Inc. | DYB | Class II | |
| K034051 | Dynatrac, Cod. 50-1A | 3D Line USA, Inc. | IYE | Class II | |
| K033946 | Lovely System | Msq (M2), Ltd. | FTC | Class II | |
| K032845 | Easy Comfort Deluxe Manual Breast Pump, Model 1187 | The First Years, Inc. | HGY | Class I | |
| K032797 | Delight Dental Er: Yag Laser System | Hoya Photonics, Inc. | GEX | Class II | |
| K032794 | Custodiol | Dr. Franz Kohler Chemie GmbH | MSB | Class II | |
| K032139 | Reaads Von Willebrand Factor Activity Test Kit, Model 10826 | Corgenix, Inc. | GGP | Class II |