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 |
|---|---|---|---|---|---|
| K061570 | I-Style Bone Marrow Aspiration Needle | Busse Hospital Disposables | KNW | Class II | |
| K061547 | Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular Liner | Wrightmedicaltechnologyinc | LPH | Class II | |
| K061525 | Ge Vivid - I | General Electric Co. | IYN | Class II | |
| K061356 | Polyurethane Infusion Catheter, Alpha Cath, Model Pac20, and Polyurethane Infusion Catheter, Multi Drip, Model Pmd20-6 | Advanced Infusion, Inc. | MED | Class II | |
| K061333 | Urgent Pc Neuromodulation System, Models Upc200-a and Upc250-12 | Uroplasty, LLC | NAM | Class II | |
| K061327 | Bd Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (Gn) 0.5/0.25-32/16 Ug/ml, Ampicillin-Sulbactam (Gn) 0. | Becton Dickinson & Co | LON | Class II | |
| K061292 | Statarius, Model 001 003 | Kinetic Surgical, LLC | GCJ | Class II | |
| K061284 | I-Cat Scanner | Dental Imaging Technologies Corporation | MUH | Class II | |
| K061222 | Injectra Injection Needle | Medi-Globe GmbH | FBK | Class II | |
| K061156 | Endopath Endocutter 60 Endoscopic Linear Cutter, Models Ec60, Sc60 and Long60 and Endopath & Proximate Linear Cutters | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K061116 | Mobillife - Model (Mobil Raizer 22) - Power Wheelchair | Mobilife, LLC | ITI | Class II | |
| K061093 | Cholinesterase Gen.2 Test System | Roche Diagnostics GmbH | DIH | Class I | |
| K061060 | Tt101, Models Tt 101-1,-2,-3,-4,-5,-6,-7,-8 | Tissue Technologies Holdings, LLC | FRO | Unclassified | |
| K060809 | Osteo-Link Bone Void Filler Pellets | Promed Advance Technology Co., Ltd. | MQV | Class II | |
| K060494 | Easytac Anchor. Easytac Delivery System | Medchannel, LLC | GDW | Class II | |
| K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism Controls | Ortho-Clinical Diagnostics, Inc. | CGR | Class II | |
| K053336 | Staxx Fx System | Spine Wave Inc | NDN | Class II | |
| K051704 | Mykres Spinal System | Showa Ika Kohgyo Co., Ltd. | MNI | Class II | |
| K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | KPS | Class II | |
| K061538 | Alara Crystalview Computed Radiography System, Model R200 | Alara, Inc. | MQB | Class II | |
| K061488 | Cts-5500/Cts-6600 Ultrasonic Pulsed Echo Imaging System | Shantou Institute of Ultrasonic Instruments (Siui | IYN | Class II | |
| K061459 | Tranquil Tri-Bte | General Hearing Instruments, Inc. | KLW | Class II | |
| K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | DYX | Class II | |
| K061218 | Dimension Vista System Chemistry Calibrator 4, Model Kc140 | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K061197 | Kawasumi Laboratories Empty Solution Container | Kawasumi Laboratories Co., Ltd. | KPE | Class II | |
| K061147 | Opteryx Anterior Cervical Plate System | Innovasis, Inc | KWQ | Class II | |
| K061115 | Speedflow 0.2Um Filter, Model 11214; Speedflow 1.2Um Filter, Model 11215; Easydrop Controller, Model 11216 | Gvs SpA | FPA | Class II | |
| K061003 | Sfb & Cfb Implants | Nobel Biocare AB | DZE | Class II | |
| K053571 | Microgel Alkaline Hemoglobin Electrophoresis Test System, Microgel Acid Hemoglobin Electrophoresis Test System | Interlab S.r.l. | JBD | Class II | |
| K053373 | Atlantis Abutment for Zimmer Interface | Atlantis Components, Inc. | NHA | Class II | |
| K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | QEZ | Class II | |
| K061672 | Synapse Mip/mpr Image Visualization Software Obliquus | FUJIFILM Healthcare Americas Corporation | LLZ | Class II | |
| K061671 | Syngo Trued, Model Vc10a | Siemens Medical Solutions | LLZ | Class II | |
| K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | CBK | Class II | |
| K061558 | Microlife Wrist Watch Blood Pressure Monitor, Model Bp3bu1-4U | Microlife Intellectual Property GmbH | DXN | Class II | |
| K061407 | Primatrix Dermal Repair Scaffold | Integra LifeSciences Braintree Inc. | KGN | Unclassified | |
| K061400 | Calcaneal Trauma System | TORNIER Inc. | HRS | Class II | |
| K061039 | Amsure Disposable Syringe With/without Needle | Amsino International, Inc. | FMF | Class II | |
| K060908 | Sonohysterography Biopsy Device | Cook Incorporated | PGK | Class II | |
| K060901 | Vashe Wound Cleansing System | Sterilox Technologies, Inc. | FRO | Unclassified | |
| K060759 | Y-Click Connector | Elcam Medical A.C.A.L. | DTL | Class II | |
| K060666 | Carotid Access Kit | Terumo Medical Corp. | DYB | Class II | |
| K060616 | Nposes (Nocturnal Pulse Oximetry Study Expert System), Model Nposes-100 | PHD Medical | DQA | Class II | |
| K051336 | Geratherm Sos-Rescue Bag | R.G. Enterprises, Inc. | DWJ | Class II | |
| K051278 | Geratherm Sos-Vacutherm (Thermamed Smartcare) | Rg Ent., Inc. | DWJ | Class II | |
| K061261 | L4 Oxygen Concentrator | Respironics, Inc. | CAW | Class II | |
| K061174 | Surgi-Max | Ellman Intl., Inc. | GEI | Class II | |
| K060924 | Jsz Multiaction Gp Contact Lens Solution | Szabocsik and Associates | LPN | Class II | |
| K060874 | Depuy Global Ap Shoulder System | Depuy Orthopaedics Inc. | KWS | Class II | |
| K060518 | Partial Ossicular Replacement Prostheses | Grace Medical, Inc. | ETB | Class II |