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 |
|---|---|---|---|---|---|
| K082250 | Auragen Cortical Surface Electrodes | Integra NeuroSciences | GYC | Class II | |
| K082236 | Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K082220 | Somatom Flash Ds | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K082052 | Masimo Rainbow Set Radcheck Pulse Co-Oximeter, Radcheck, Rad 57 Spot Check | Masimo Corporation | DQA | Class II | |
| K082046 | Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/acui and Circon Aur-735 Pediatric Cystouretherosco | Karl Storz Endoscopy-America, Inc. | FBO | Class II | |
| K082018 | T2 Flexible Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K082017 | Starr Frame Steinmann Pin | Starr Frame LLC | HTY | Class II | |
| K081890 | Sysmex Xt-Series Ig Parameter,sysmex Xt-Series Ret-He Parameter | Sysmex America, Inc. | GKZ | Class II | |
| K081832 | Ensplintcmx Clavicle Pin | Sonoma Orthopedic Products, Inc. | HSB | Class II | |
| K081717 | Tricos a Resorbable Bone Substitute | Baxter Healthcare Corporation | MQV | Class II | |
| K081654 | Hem-9000Ai | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K081107 | Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors | K2M, Inc | KWP | Class II | |
| K080851 | A/c Portable Enzymatic Homocysteine Assay | Anticancer, Inc. | LPS | Class II | |
| K080399 | Dbx Demineralized Bone Matrix Putty, Dbx Demineralized Bone Matrix Paste | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | MBP | Class II | |
| K073522 | Vitrification Kit & Vitrification Warming Kit | Sage In-Vitro Fertilization, Inc. | MQL | Class II | |
| K073368 | 5.0 X 5.0Mm Dental Implant and 6.0 X 5.0 Dental Implant | Bicon, LLC | DZE | Class II | |
| K082802 | Mipump Single Electric/battery Breat Pump & Mipump Double Electric/battery Breast Pump & Mipump Deluxe Double Electric/b | Learning Curve Brands Inc. the First Years | HGX | Class II | |
| K082601 | UltraClot, UltraClot OTC | Emergency Medical Devices, LLC | QSY | Unclassified | |
| K082330 | Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation | Primary Care Solutions, Inc. | FRO | Unclassified | |
| K082237 | Puritan Bennett, Sandman Duo and Sandman Duo St | Mallinckrodt Developpement France | BZD | Class II | |
| K081997 | Perfadex with Tham | Vitrolife Sweden AB | MSB | Class II | |
| K081670 | The Advantage Series Non-Vented (Nv) Full Face Mask | Cardinal Health 207, Inc. | CBK | Class II | |
| K081385 | Uresta Pessary | Eastmed, Inc. | HHW | Class II | |
| K081321 | Modification to Mirage Micro | ResMed Corp | BZD | Class II | |
| K081178 | Optimum Hr-1.51 (Hiflufocon a) and Hr-1.53 (Hiflufocon B) Daily Wear Contact Lenses | Contamac Ltd. | HQD | Class II | |
| K081053 | Pivot Assist | Pivot Assist, LLC | INO | Class II | |
| K080559 | Dio Sm Implant System | Dsi, Inc. | DZE | Class II | |
| K080348 | Oxiscan II Data Management System | Airsep Corp. | DQA | Class II | |
| K080347 | Uniscan -Doa System | Taiwan Unison Biotech, Inc. | DJC | Class II | |
| K080275 | Npd 1000 Negative Pressure Wound Therapy System | Iasis Medical, Inc. | OMP | Class II | |
| K080194 | Vidas Cea (S) Assay | bioMerieux, Inc. | DHX | Class II | |
| K082816 | Ge Brightspeed Delight CT Scanner System | GE Healthcare | JAK | Class II | |
| K082815 | Well Lead Silicone and Latex Foley Catheters | Well Lead Medical Instruments | EZL | Class II | |
| K082761 | Ge Lightspeed 7.2 CT Scanner System | GE Healthcare | JAK | Class II | |
| K082657 | Rtx Respirator | Medivent Limited | BYT | Class II | |
| K082592 | Ldr Spine Easyspine System | Ldr Spine USA | NKB | Class II | |
| K082486 | Glucofacts Express Diabetes Management Software | Medrad, Inc. | NBW | Class II | |
| K082420 | Tracheoscopic Ventilation Tube (Tvt) | Etview, Ltd. | BTR | Class II | |
| K082326 | Zonare Ultra Ultrasound System | Zonare Medical Systems, Inc. | IYN | Class II | |
| K082311 | Exsudex Wound Drainage Pump | Medical, Inc. | OMP | Class II | |
| K082280 | Suresigns Vs2 Vital Signs Monitor, Suresigns Vm1 Patient Monitor, Suresigns Vs3 Cital Signs Monitor | Philips North America LLC | MHX | Class II | |
| K082247 | Evis Md Platinum Red Light Therapy | Ageless Beauty Corporation | GEX | Class II | |
| K082242 | Icon, Model C3 | Osypka Medical GmbH | DSB | Class II | |
| K082229 | S5/s5i Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System | Volcano Corporation | IYO | Class II | |
| K082202 | Halo360 Energy Generator, Models 1100C-115B and 1100C-230B | Barrx Medical, Incorporated | GEI | Class II | |
| K082103 | Ltm Wound Dressing | LifeCell Corp | KGN | Unclassified | |
| K082096 | Powerlipo Laser System | Lutronic Corporation | GEX | Class II | |
| K081884 | Major.base 20 | Major Prodotti Dentari S.p.A. | EBI | Class II | |
| K081681 | Vitrectomy Cutter and Accessories | Advanced Medical Optics, Inc. | MLZ | Class II | |
| K081447 | Fourth Gas Module with CO2 for Primus US Apollo | Draeger Medical AG & Co. KG | BSZ | Class II |