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 |
|---|---|---|---|---|---|
| K022979 | Laparette, Model Lap J L S H N | Instruments Medicaux G.B., Inc. | KNF | Class II | |
| K022945 | Autostat II Anti-B-2 Glycoprotein I Igg Elisa | Hycor Biomedical | MSV | Class II | |
| K022944 | Autostat II Anti-B-2 Glycoprotein-I Igm Elisa | Hycor Biomedical | MSV | Class II | |
| K022713 | Dfa Respiratory Virus Screening & Id Kit | Ortho-Clinical Diagnostics, Inc. | GNW | Class I | |
| K011723 | Anti-Snoring Device or Asd | Pi Medical | LRK | Class II | |
| K023986 | Arthrex Opes Electrodes and Accessories | Arthrex GmbH | GEI | Class II | |
| K023894 | St Aia-Pack Afp Enzyme Immunoassay | Tosoh Medics, Inc. | LOJ | Class II | |
| K023867 | Mas T-Marker, Level 1,2 and 3, Dade Special-T Marker, Level 1,2 and 3 | Medical Analysis Systems, Inc. | JJY | Class I | |
| K023560 | Environ-Np Disposable Vinyl Exam Gloves, Powdered | Shanghai Palomar Mountain Industries, Inc. | LYZ | Class I | |
| K023539 | Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow, Transflow | Valumed | LHI | Class II | |
| K023185 | Annuloflex Annuoplasty System, Model Af 800 | Sulzer Carbomedics, Inc. | KRH | Class II | |
| K023152 | Immulite 2000 Allergen-Specific Ige | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K023132 | Jostra Mecc System | Jostra AG | KFM | Class II | |
| K023112 | Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9 | Problem Solving Concepts, Inc. | DQK | Class II | |
| K023094 | Iridis Ophthalmic Photocoagulator | Quantel Medical | HQF | Class II | |
| K023091 | St Aia-Pack Testosterone Assay | Tosoh Medics, Inc. | CDZ | Class I | |
| K022288 | Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System | Bayer Corp. | LTJ | Class II | |
| K022185 | Universal Cmf System | Stryker Corp. | JEY | Class II | |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular System | Bayer Diagnostics Corp. | LTJ | Class II | |
| K022028 | Vx-400 Topical Hyperbaric Oxygen Chamber | Vascular One, Inc. | KPJ | Class II | |
| K020683 | Isorod Pd-103 Implant, Model Ati-Pd-103 | Ati Medical, Inc. | KXK | Class II | |
| K023489 | Quicktox Multiple Drug Dipcard | Branan Medical Corp. | DIO | Class II | |
| K023405 | Trojan Mint Tingle Brand Latex Condoms | Armkel, LLC | HIS | Class II | |
| K023397 | Abbott Architect Folate | Abbott Medical | CGN | Class II | |
| K023361 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Gatifloxacin (0.004-16 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K023316 | Single Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International Inc | DLJ | Class II | |
| K023109 | Amedica Drug Screen Phencyclidine Test | Amedica Biotech, Inc. | LCM | Unclassified | |
| K023104 | Amedica Drug Screen Amphetamine Test | Amedica Biotech, Inc. | DKZ | Class II | |
| K023101 | Amedica Drug Screen Methaphetamine Test | Amedica Biotech, Inc. | LAF | Class II | |
| K023089 | Gelspheres Embolic Agent | Biocure, Inc. | HCG | Class II | |
| K023087 | Global Modular Replacement System (Gmrs) | Howmedica Osteonics Corp | KRO | Class II | |
| K023084 | Model 472Ge-128: Quadrature Lower Extremity Coil | Medical Advances, Inc. | MOS | Class II | |
| K023081 | Prolite / Plasmalite Mpx Pulsed Light System (Permanent Hair Reduction) | Medical Bio Care Sweden AB | GEX | Class II | |
| K023027 | Preg-Q Early Pregnancy Test | YD Diagnostics | LCX | Class II | |
| K022762 | Jowire Neo's Ptca Catheter Guidewires, Models Ag141000, Ag142000, Ag143000, Ag141002, Ag141010, Ag14m060 & Ag14m050 | Jomed AG | DQX | Class II | |
| K022683 | Sas Blood/serum/urine/urine Hcg | SA Scientific, Ltd | JHI | Class II | |
| K021699 | Autolens Cleaning and Disinfecting Unit | Autolens, Inc. | LYL | Class II | |
| K020482 | Keratome Blade 200200 & 600600 | Micro Specialties, Inc. | HNO | Class I | |
| K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | MUD | Class II | |
| K023853 | K-Assay Lp(a) Controls | Kamiya Biomedical Company, LLC | DFC | Class II | |
| K023832 | Surestep Hospital Blood Glucose Monitoring System | Lifescan, Inc. | NBW | Class II | |
| K023827 | Paragon Infusion System with Bolus | Halyard Health | FRN | Class II | |
| K023797 | Laurain Dewald Anterior Fixation System | Medtronic Sofamor Danek | KWP | Class II | |
| K023788 | Columbus (Cr) Total Knee System | Aesculap Inc | JWH | Class II | |
| K023717 | Sperm Wash Medium with Gentamicin | Conception Technologies | MQL | Class II | |
| K023655 | Enhance Htf Medium with Hepes | Conception Technologies | MQL | Class II | |
| K023541 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Moxifloxacin (0.004-16Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K023500 | Digital Clinical Thermometer, Model Baby Temp/wl-3305 and Baby Temp (+) /Wl-3306 | Innovatech, Inc. | FLL | Class II | |
| K023491 | Automed 3300 and 3400 Infusion Pump System | Help Technologies | FRN | Class II | |
| K023477 | Bioloy | Neirynck & Vogt NV | EJH | Class II |