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 |
|---|---|---|---|---|---|
| K071064 | Ascension Humeral Resurfacing Arthoplasty (Hra) System Tps/ha | Ascension Orthopedics, Inc. | HSD | Class II | |
| K071025 | Zoll Aedpro with See-Thru CPR, Model Aedpro | ZOLL Medical Corporation | MKJ | Class III | |
| K070995 | Arx-Link Cross Connector | Life Spine | NKB | Class II | |
| K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | NHA | Class II | |
| K070675 | Mammaprint | Agendia Inc | NYI | Class II | |
| K070647 | Triflex Select | Medtronic, Inc. | KGO | Class I | |
| K070524 | Microdot Blood Glucose Monitoring System | Cambridge Sensors Limited | NBW | Class II | |
| K070383 | Enzymatic Creatinine Assay (265 Series) | Sekisui Diagnostics P.E.I. Inc. | JFY | Class II | |
| K070303 | Silicone Tissue Expander | Specialty Surgical Products, Inc. | LCJ | Unclassified | |
| K063388 | Topcon 3D Oct-1000 Optical Coherence Tomography System | Topcon Corp. | OBO | Class II | |
| K071430 | Synerad Omni, Models An6255 and An6265 | Analogic Corp. | KPR | Class II | |
| K071002 | Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (Ccrp) Reagent | Siemens Healthcare Diagnostics Inc. | NQD | Class II | |
| K070975 | Symmetry Iq, Model 2000 Series, 3000 Series | HU-Friedy Mfg. Co. LLC | ELC | Class II | |
| K070941 | Clever Chek Health Care System Software, Version 1.0 | Taidoc Technology Corporation | NBW | Class II | |
| K070924 | Flexguard | Allmed Systems, Inc. | GEX | Class II | |
| K070841 | Endosseous Dental Implant System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid Test | Alfa Scientific Designs, Inc. | KHE | Class II | |
| K070610 | Skater Biliary Catheter | Angiotech | FGE | Class II | |
| K070596 | Topical Applicator | Sharn, Inc. | CCT | Class II | |
| K070533 | Bti Endosseous Dental Implant Angled Abutments | B.T.I. Biotechnology Institute, S.L. | NHA | Class II | |
| K070491 | Digital Forehead Thermometer, Model# Kd-2200 | K-Jump Health Co., Ltd. | FLL | Class II | |
| K070159 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | DRE | Class II | |
| K063605 | St Aia-Pack Intact Pth Assay | Tosoh Bioscience Inc | CEW | Class II | |
| K062372 | Freelite Human Kappa and Lambda Free Kits for Use on the Spaplus Analyzer | The Binding Site | DFH | Class II | |
| K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | KGN | Unclassified | |
| K071399 | Dose Verification System Patient Dosimetry System, Model Dvs-I-11: Dvs Insertion Tool, Dvs-D-a: Dvs Dosimeter, Dvs-R-100 | Sicel Technologies, Inc. | LHN | Class II | |
| K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | MWP | Class II | |
| K071232 | Image-Arena Applications and Research-Arena Applications | TOMTEC Imaging Systems GmbH | LLZ | Class II | |
| K071195 | Khbs (Krishnamurthy Hepato-Biliary Software), Model Version 1.5 | Ani-Kal Ii, LLC | IYX | Class I | |
| K071180 | Scintillant Surgical Light, Model 2644-01-0001 | Engineered Medical Solutions Co., LLC | FTD | Class II | |
| K071169 | Clearfil Majesty Posterior Plt | Kuraray Medical, Inc. | EBF | Class II | |
| K070917 | Feel-Ject Insulin Syringe | Feel Tech | FMF | Class II | |
| K070815 | Thd | G.F. S.r.l. | JAF | Class II | |
| K070666 | Genesiscs Component Concentrating System | Perfusion Partners & Assoc., Inc. | JQC | Class I | |
| K070490 | Cirqlator Intrathoracic Pressure Regulator (Itpr) | Advanced Circulatory Systems, Inc. | BWF | Class II | |
| K063818 | Quanta Plex Celiac Iga Profile | Inova Diagnostics, Inc. | MVM | Class II | |
| K063753 | Gfx Nerve Ablation System | Aci, Inc. | GXD | Class II | |
| K063282 | Contiplex Stim Continuous Nerve Block Set | B.Braun Medical, Inc. | CAZ | Class II | |
| K062558 | Mesosfol Surgical Film | Biomet Manufacturing Corp | FTM | Class II | |
| K063232 | Architect Intact Pth Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01 | Biokit, S.A. | CEW | Class II | |
| K071125 | Amplatzer Vascular Plug II Models: Avp2-004, Avp2-006, Avp2-008, Avp2-010, Avp2-012, Avp2-014, Avp2-016 | Abbott Medical | KRD | Class II | |
| K071020 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-Cicu05 and L-Cicu05a Software | GE Healthcare | MHX | Class II | |
| K070288 | Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar Xl, 60814 | Medtronic, Inc. | OCL | Class II | |
| K062613 | Bis EEG Monitor View | Aspect Medical Systems, Inc. | OLW | Class II | |
| K071387 | Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-Lb | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K070901 | Modified Plate Design for Bioplate Zip Craniotomy Fixation System | Bioplate Inc | GXN | Class II | |
| K070869 | Prophy Star 3 Hygiene Handpiece, Model 264422 | Dentalez, Inc. | EFB | Class I | |
| K070656 | Hydrocoil Embolic System (Hes) | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K070639 | Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K070263 | Apnealink | Resmed Germany, Inc. | MNR | Class II |