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 |
|---|---|---|---|---|---|
| K091158 | Scalar Wave Laser System | Stellar Lasers | ILY | Class II | |
| K090978 | Uc-Care Warming System | UC-Care | GEH | Class II | |
| K090662 | Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ Dbip | Masimo Corporation | DQA | Class II | |
| K082886 | Zoom-100Dc | Brainscope | OLT | Class II | |
| K082016 | Gdx Vcc with Ecc Software | Carl Zeiss Meditec Inc | MYC | Class II | |
| K081268 | Sonic Air Mm1500 + (Mid), Model 50400014 | Micro-Mega Societe Anonyme | ELC | Class II | |
| K092343 | En Snare Endovascular Snare System | Merit Medical Systems, Inc. | MMX | Class II | |
| K092299 | Trailblazer Support Catheter | Ev3, Inc. | DQY | Class II | |
| K092136 | Proxcelan Cs-131 Preloaded Braided Strands, Model: Pl-5 | Isoray Medical, Inc. | KXK | Class II | |
| K092075 | Cps Direct Sl II Slittable Outer Catheter, Models Ds2c001, Ds2c002, Ds2c003, Ds2c004, Ds2c005 | St. Jude Medical, Cardiac Rhythm Management Divisi | DQY | Class II | |
| K092073 | Monopoly Pedicle Screw System | Signus Medical, LLC | NKB | Class II | |
| K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12 | Biosense Webster Inc | OBJ | Class II | |
| K091995 | Laguna Size 8 Pedicle Screw System | Allez Spine, LLC | NKB | Class II | |
| K091856 | Conmed ECG Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700, 2710, 1800, Series | ConMed Corporation | DRX | Class II | |
| K091773 | Fujinon Sterile Overtubes | FUJIFILM Healthcare Americas Corporation | FED | Class II | |
| K091702 | Cdb Flip-Side-Clip Bracket | CDB Corporation | NJM | Class II | |
| K091633 | Tephaflex Surgical Film | Tepha, Inc. | OOD | Class II | |
| K091626 | Cryopatch Sg Pulmonary Hemi-Artery; Trunk; Branch | Artivion, Inc. | DXZ | Class II | |
| K091554 | Pharmapac Personal Lubricant | Pharmapac, LLC | NUC | Class II | |
| K091548 | Amco Replacement Battery for Philips Medical Models Bt1 and M5070a | Amco International Manufacturing & Design, Inc. | MKJ | Class III | |
| K091385 | Approach Hydro St Wire Guide, Model Hmw | Cook Inc. | DQX | Class II | |
| K091381 | Ibex Spinal System | Ebi, LLC | MAX | Class II | |
| K091324 | Sherlock 3Cg Tip Positioning System, Sherlock 3Cg Tip Positioning System Stylet | C.R. Bard Inc | LJS | Class II | |
| K091165 | Horizon Xvu | Mennen Medical, Inc. | DQK | Class II | |
| K091098 | Kowagenesis-Df | Kowa Co., Ltd. | HKI | Class II | |
| K091041 | Rigidfix Biocryl 2.7Mm Btb (210815), Femoral 3.3Mm St (210816), and Tibial 3.3Mm St (210817) Cross Pin Kits | DePuy Mitek, Inc. | MAI | Class II | |
| K091039 | Kowa, Fm-600, Model Lss50 | Kowa Co., Ltd. | MYC | Class II | |
| K090791 | Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5% | Century Pharmaceuticals, Inc. | FRO | Unclassified | |
| K090586 | Bovie Icon Gs Electrosurgical Generator (Gs100), Handpiece (Gs-Op-R), Reusable Handpiece Cable (Gs807-Rc) | Apyx Medical Corporation | GEI | Class II | |
| K090493 | Signal | Zargis Medical Corp. | DQD | Class II | |
| K090002 | Acid Concentrate 45X (2.0K, 3.1Ca), Model 5M8001a, Acid Concentrate 45X (2.0K, 2.5Ca), Model 5M8002a | Baxter Healthcare Corporation | KPO | Class II | |
| K083643 | Verify 275F Gravity Indicators | STERIS Corporation | JOJ | Class II | |
| K083429 | i.v. Catheter, Models: Type I, Type Y, Type Straight | Weihai Jierui Medical Products Co., Ltd. | FOZ | Class II | |
| K083087 | Ecocel | Polichem SA | KMF | Class I | |
| K083053 | Euroimmun Anti-Gliadin (Gaf-3X) Elisa (Igg) | Euroimmun US Inc. | MST | Class II | |
| DEN080011 | Snap Wound Care Device | Spiracur, Inc. | OKO | Class II | |
| K092235 | Beyondimage Workstation | Neusoft Medical Systems Co., Ltd. | LLZ | Class II | |
| K092079 | Modification to Ge Vivid S5 and S6 Diagnostic Ultrasound | GE Medical Systems Israel, Ultrasound, Ltd. | IYN | Class II | |
| K091460 | Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087 | American Biological Technologies, Inc. | JJX | Class I | |
| K091365 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Soafamor Danek | KWP | Class II | |
| K091289 | Immulite 2000 3Gallergy Specific Ige Assay Kit | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K091167 | Shina Insulin Syringe-Including Accu-Sure Insulin Syringes | Shina Corp. | FMF | Class II | |
| K090358 | Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35 | Abbott Medical | LEG | Class II | |
| K090240 | Monteris Medical Ufo | Monteris Medical Corp | HAW | Class II | |
| K090107 | Mini Tightrope | Arthrex GmbH | HTN | Class II | |
| K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (Vng), I-Portal Neuro Otol | Spryson America Inc | GWN | Class II | |
| K092078 | Optilock Periarticular Plating | Biomet Trauma | HRS | Class II | |
| K092043 | BIPAP Synchrony 2 | Respironics, Inc. | MNS | Class II | |
| K091648 | Nurse's Assistant o.r. Control System ,1.8 | Conmed Integrated Systems (Cmis) | GCJ | Class II | |
| K091396 | Cardo Medical Anterior Cervical Plate System | Cardo Medical Corp. | KWQ | Class II |