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 |
|---|---|---|---|---|---|
| K000848 | Tdk Handpieces | Orasystems | EFB | Class I | |
| K002962 | Pressure Wire Sensor, Model 12003/12303 | Radi Medical Systems AB | DQX | Class II | |
| K002772 | Ascent Xxl Closed Box Femoral Component | Zimmer GmbH | JWH | Class II | |
| K002484 | Ems Swiss Orthoclast Chisels for Non-Cemented Prosthesis Removal | E.M.S. - Electro Medical Systems SA | JDX | Class II | |
| K002289 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | |
| K002074 | Ab Cardiette Daedalus View Base and Ab Cardiettte Daedalus View Hes | H&C Medical Devices SpA | DPS | Class II | |
| K002057 | Brooker Tibia Nails | Biomet Orthopedics, Inc. | HSB | Class II | |
| K001460 | Vidas H. Pylori Igg (Hpy) Assay, Model 30 192 | bioMerieux, Inc. | LYR | Class I | |
| K001125 | Geuder Injector for Morcher Capsular Tension Ring | Geuder AG | NCE | Class I | |
| K002836 | Media for Gamete Preparation and Embryo Culture | Sage Biopharma | MQL | Class II | |
| K002568 | Polymer Coat, Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | Smart Glove Corp. Sdn Bhd | LYY | Class I | |
| K002490 | Indomitable Magnetic Resonance Imaging Scanner | Fonar Corp. | LNH | Class II | |
| K002213 | Bull's-Eye Disposable Needle Recapping Aid | Hunter Research Laboratories, Inc. | FMI | Class II | |
| K001703 | Perclose Vascular Suture Delivery Device | Abbott Vascular | GAW | Class II | |
| K002732 | Stryker Navigation System - ENT Module | Stryker Corp. | HAW | Class II | |
| K002437 | Endius Endoscopic Access System | Endius, Inc. | HRX | Class II | |
| K002296 | Ceralas G15 532Nm Frequency Doubled Nd:yag Laser, Model G1-G15 | Ceram Optec, Inc. | GEX | Class II | |
| K002294 | Biocheck Testosterone Eia, Model Bc-1115 | BioCheck Inc | CDZ | Class I | |
| K002078 | Beta Glucan Gel (Macropro Gel) | Brennen Medical, Inc. | MGQ | Unclassified | |
| K002077 | Glucanpro Cream | Brennen Medical, Inc. | MGQ | Unclassified | |
| K001464 | Disposable H-Pe Microkeratome Blades | Oasis | HNO | Class I | |
| K000003 | Tornier Total Elbow Prosthesis | TORNIER Inc. | JDC | Class II | |
| K994112 | Manual Her-2/Neu Microtiter Elisa (Osdi Her-2/Neu Elisa) | Oncogene Science, Inc. | NCW | Class II | |
| K994008 | Biosys Fetal Monitor, Model Ifm-500 | Biosys Co., Ltd. | HGM | Class II | |
| K992228 | Bayer Immuno 1 Her-2/Neu Assay | Bayer Corp. | NCW | Class II | |
| K002710 | Modification to Synthes (USA) Trochanter Stabilization Plate (Tsb) for Dhs (Line Extension) | Synthes (USA) Products LLC | HRS | Class II | |
| K002451 | Modification to: Pronto Dry | Medical Instruments S.p.A. | LYR | Class I | |
| K002028 | Bravo Ph Monitoring System | Endonetics, Inc. | FFT | Class I | |
| K002013 | Omniport | Advanced Surgical Concepts (Asc) | GCJ | Class II | |
| K001056 | Olympic Warm-Up | Olympic Medical Corp. | ILY | Class II | |
| K002833 | Modification to Standard Imaging Pt 1000 Ion Chamber | Standard Imaging Inc. | KPT | Class II | |
| K002796 | Modification to Provident Hip System | Globus Medical, Inc. | LWJ | Class II | |
| K002776 | Modification to Profile -II | MEDTOX Diagnostics, Inc. | LCM | Unclassified | |
| K002723 | Rebar Micro Catheter: Rebar-10 (1.7F), 153 Cm, Dual Marker Bands; Rebar Micro Catheter: Rebar-10 (1.7F), 170 Cm, Dual Ma | Medtronic, Inc. | KRA | Class II | |
| K002711 | Hologic Qdr X-Ray Bone Densitometer/models Series 4500, 4000, 2000, 1000 and Hologic Delphi X-Ray Bone Densitometer | Hologic, Inc. | KGI | Class II | |
| K002452 | 3M Rely X Veneer Cement Try-in Paster | 3M Company | EMA | Class II | |
| K002387 | Comfort Control Syringe System | Dentsply Intl. | EJI | Class II | |
| K002215 | Autostat II Anti-Myeloperoxidase (Mpo) Elisa | Cogent Diagnotics, Ltd. | MOB | Class II | |
| K002144 | Medlink Diagnostic Offline Workstation | Advanced Technology Laboratories, Inc. | LLZ | Class II | |
| K001833 | Preference Treatment System | Northwest Medical Physics Equipment, Inc. | IYE | Class II | |
| K991977 | Tyshak, Model 102 and Z-Med, Model 302 | Numed Inc | LIT | Class II | |
| K002767 | Compressar Femoral Access Compression Device | Semler Technologies, Inc. | DXC | Class II | |
| K002399 | Modification to Cd Horizon Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K002346 | Wire, Guide, Catheter, Model Qsw1000 | Medtronic, Inc. | DQX | Class II | |
| K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | LMC | Class II | |
| K002039 | Ecat Pet Scanner, Models Ecat Exact and Ecat Exact Hr+ and Ecat Art | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K001986 | Surgitron Iec II | Ellman Intl., Inc. | GEI | Class II | |
| K001984 | Progeny Forged Cocr Cemented Femoral Component | Globus Medical, Inc. | JDG | Class II | |
| K001980 | Aspect Medical Systems Pediatric Bis EEG Sensor, Model 186-0110 | Aspect Medical Systems, Inc. | GXY | Class II | |
| K000847 | Oralube | Orasystems | EFB | Class I |