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 |
|---|---|---|---|---|---|
| K981859 | Surgiflator-20 Ecu | Novanta Medical GmbH | HIF | Class II | |
| K981833 | Silimed Nasal L Shaped Implant | Silimed, LLC | FZE | Class II | |
| K981728 | Alexander Manufacturing Co. Battery Part Number H134 | Alexander Mfg. Co. | BZQ | Class II | |
| K981214 | Osteograf/n-700 | Ceramed Dental, LLC | LYC | Class II | |
| K981131 | Pathfinder Mobile C Arm | Acoma Medical Imaging, Inc. | OXO | Class II | |
| K980813 | Reliance Long Stem Femoral Components | Howmedica Corp. | JDI | Class II | |
| K980779 | Thalafix Natural Sea Salt Dressing | Dumex Medical Surgical Products, Ltd. | KMF | Class I | |
| K980132 | Phytacare Alginate Hydrogel Wound Dressing | Phytatek Laboratories, Inc. | MGQ | Unclassified | |
| K974178 | Passport 5L-Ce Model 0998-00-0131Xxx | Datascope Corp. | DRT | Class II | |
| K973298 | Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter | Cardima, Inc. | DQY | Class II | |
| K965117 | Life Support for Trauma and Transport | Northrop Grumman Corp. | MKJ | Class III | |
| K964514 | Corpak Medsystems Cruz Catheter for Peritoneal Dialysis | Corpak Co. | FKO | Class II | |
| K963440 | Dialog Dialysis Machine | B Braun Medical Inc | KDI | Class II | |
| K982097 | Worldwide Medical Technologies Intracervical Block Needle, Model Tbd | Worldwide Medical Technologies, LLC | FMI | Class II | |
| K982009 | One Week Backstop Dental Anti-Retraction Check Valve | Scitech Solutions, Inc. | EIA | Class I | |
| K981935 | Polysorb Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K981902 | Spenco Silicone Gel Sheet | Spenco Medical Corp. | MDA | Class I | |
| K981838 | Accustrip Hcg-Urine Model Number Hcg-002 | Unotech Diagnostics, Inc. | JHI | Class II | |
| K981610 | Careside Analyzer | Careside, Inc. | CEO | Class I | |
| K981604 | Careside Uric Acid | Careside, Inc. | KNK | Class I | |
| K981506 | Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev) | Repro-Med Systems, Inc. | LKY | Class II | |
| K981476 | Chol | Abbott Medical | CHH | Class I | |
| K981461 | Gc Fuji Ortho Lc | GC America Inc. | DYH | Class II | |
| K981443 | Biosign Hcg I - One Step Pregnancy Test | Princeton BioMeditech Corp. | JHI | Class II | |
| K981433 | Orthodontic Braces | Midwest Orthodontic Mfg. | DYW | Class II | |
| K981302 | Smc 28Mm Ceramic Femoral Heads | Whiteside Biomechanics, Inc. | LZO | Class II | |
| K981275 | Synthes (USA) Ratcheting Distractor | Synthes (USA) Products LLC | MQN | Class II | |
| K981271 | Clearplan Easy Ovulation Test | Unipath, Ltd. | CEP | Class I | |
| K981140 | Minrad Drts Light Saber Syringe | Minrad, Inc. | FMF | Class II | |
| K981126 | Ceralas G Frequency Doubled Nd: Yag Laser Systems, Ceralas G3 | Ceram Optec, Inc. | GEX | Class II | |
| K981115 | Radio-Plast | Smith & Nephew, Inc. | LHN | Class II | |
| K981114 | Microcap | Oridion Medical, Ltd. | CCK | Class II | |
| K980948 | Ved Valu- Vacuum Erection Device | Mission Pharmacal Comp | LKY | Class II | |
| K980580 | Becton Dickinson Syringes | BD Becton Dickinson Vacutainer Systems Preanalytic | FMF | Class II | |
| K961320 | Cross Medical Bone Plate System/ Cm Bone Plate System/cross Ti Bone Plate System | Buckman Co., Inc. | HWC | Class II | |
| K982174 | Venturi Ventilator | Cardiopulmonary Corp. | CBK | Class II | |
| K982056 | Raichem CO2 Reagent | Reagents Applications, Inc. | KHS | Class II | |
| K982035 | Olympus Calcium Arsenazo III Reagent | Olympus Diagnostica GmbH | CJY | Class II | |
| K981822 | Drs System | Professional Distribution Systems, Inc. | ITH | Class II | |
| K981779 | Cantor & Silver 5X (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tinted, Lat | Cantor & Silver, Ltd. | LPL | Class II | |
| K981416 | Magnatek Electrosurgical Units Models, Esu-10, Esu-15 | Magna Advanced Technologies, Inc. | GEI | Class II | |
| K981269 | Universal Drive System | Linvatec Corporation | HRX | Class II | |
| K980591 | Renu Multiplus Lubricating & Rewetting Drops | Bausch & Lomb Incorporated | LPN | Class II | |
| K974735 | Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade & Needle; Standard 45 Degree Blade | Apyx Medical Corporation | JOS | Class II | |
| K974595 | Cushing Bayonet, Insulated Bipolar Forcep | Titan Mfg., Inc. | HTD | Class I | |
| K974594 | Semkin Bipolar Forcep | Titan Mfg., Inc. | HTD | Class I | |
| K974593 | Semkin Insulated Bipolar Forcep | Titan Mfg., Inc. | HTD | Class I | |
| K974417 | Sullivan Vpap II St-a Nasal Vpap System | ResMed Corp | MNS | Class II | |
| K982127 | Porous Media Def25 Disposable Respiratory Filter | Pentair Filtration Solutions | CAH | Class II | |
| K981588 | Careside Total Bilirubin | Careside, Inc. | CIG | Class II |