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 |
|---|---|---|---|---|---|
| K984297 | Magna Abutment | Factor, II, Inc. | DZE | Class II | |
| K000100 | Camlog Rootform Implant System | Altatec Biotechnologies | DZE | Class II | |
| K000099 | Camlog Screw Implant System | Altatec Biotechnologies | DZE | Class II | |
| K000065 | Camlog Cylinder Implant System | Altatec Biotechnologies | DZE | Class II | |
| K994216 | Plastic Port Implantable Venous Access System | Sims Deltec, Inc. | LJT | Class II | |
| K994190 | Impregum Garant L Duosoft | Espe Dental AG | ELW | Class II | |
| K994077 | Aroma Fine (Normal and Fast Set) | GC America Inc. | ELW | Class II | |
| K994030 | Ontrak Testcup 5, Cat. 07 6481 7 | Roche Diagnostics GmbH | LCM | Unclassified | |
| K994020 | Ontrak Teststik for Pcp, Cat. 07 6654 2 | Roche Diagnostics GmbH | LCM | Unclassified | |
| K994017 | Ontrak Testcup 5 M2k, Cat. 11 1850 1 | Roche Diagnostics GmbH | LCM | Unclassified | |
| K994004 | Quanta Lite Lyme B. Burgdorferi Igg/igm Elisa Kit | Inova Diagnostics, Inc. | LSR | Class II | |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ul | Syva Co. | DIO | Class II | |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029ul/9d129ul | Syva Co. | KLT | Class II | |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029ul/9q129ul | Syva Co. | KXS | Class II | |
| K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029ul/9f129ul | Syva Co. | JXM | Class II | |
| K993983 | Syva Emit II Plus Phencyclidine Assay, Model 9J029ul | Syva Co. | LCM | Unclassified | |
| K993982 | Syva Emit II Plus Amphetamine/methamphetamine Assay 9C029ul/9c129ul | Syva Co. | LAF | Class II | |
| K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | FPA | Class II | |
| K993784 | Unigraft | Unicare Biomedical, Inc. | LYC | Class II | |
| K993654 | Neurocomp | Neurocybernetics | HCC | Class II | |
| K993639 | Rx Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K993031 | Abbott Aeroset Phenobarbital Assey and Calibrators;models 1E08 and 5F54 | Syva Co. | DLZ | Class II | |
| K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89 | Syva Co. | KLS | Class II | |
| K993028 | Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90 | Syva Co. | KLT | Class II | |
| K993026 | Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin Calibrators | Syva Co. | DIP | Class II | |
| K992991 | Atrium Medical Corporation Advanta PTFE Facial Implant | Atrium Medical Corporation | FTL | Class II | |
| K992914 | Excimer Laser Phototherapy System, Al7000 | Acculase, Inc. | GEX | Class II | |
| K992632 | Immulite Amphetamine, Models Lkam1, Lkam5 | Siemens Healthcare Diagnostics Inc. | DKZ | Class II | |
| K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | ELC | Class II | |
| K992045 | Electrosurgical Electrode Family | Genesis Medical LLC | GEI | Class II | |
| K991935 | Epilight Hair Removal System, Photoderm Hr System | Esc Medical Systems, Ltd. | GEX | Class II | |
| K991355 | Metered Dose Inhaler Adapter-Disposable, Adapter Reusable | Instrumentation Industries, Incorporated | CAF | Class II | |
| K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with Scf02 - Polypropylene Non-Woven Disposabl | Case Medical, Inc. | FRG | Class II | |
| K990039 | Gambro Dqm 200 | Gambro Healthcare | LFP | Class II | |
| K994418 | Versapoint Electrosurgery System (Scuba) | Ethicon, Inc | HIH | Class II | |
| K994263 | Securline Umbilical Cord Clamp Clipper #3540 | Precision Dynamics Corporation | HFW | Class II | |
| K993961 | Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (Thc) (Cannabinoids) and Opiates (3 Panel Test for Cto) | American Bio Medica Corp. | LDJ | Class II | |
| K993671 | Candela Sclero Long Pulse Dye Laser | Candela Corporation | GEX | Class II | |
| K993622 | Neurotrek Physiological Navigation System for Neurosurgery | Alpha Omega, Ltd. | GZL | Class II | |
| K993533 | Powerheart Aecd | ZOLL Medical Corporation | MKJ | Class III | |
| K993200 | Md 420/440/460/470/480/490 | Isopure Corp | FIP | Class II | |
| K993058 | Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill | Pure Water, Inc. | FIN | Class II | |
| K992786 | Pure Water, Inc.'s Water Purification Systems | Pure Water, Inc. | FIP | Class II | |
| K990569 | Baby Dopplex 4000, Model Bd 4000 | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K994331 | Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator | Medtronic, Inc. | MXC | Class II | |
| K993768 | Citation Tmzf Ha Stem | Howmedica Osteonics Corp | MEH | Class II | |
| K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | BYI | Class II | |
| K993418 | Fibered Gdc-18 Vortx Shape Guglielmi Detachable Coil | Boston Scientific Corporation | HCG | Class II | |
| K993417 | Gdc-10 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc), Gdc-18 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc) | Boston Scientific Corporation | HCG | Class II | |
| K993415 | Gdc-10 Stretch Resistant Guglielmi Detachable Coil, Gdc-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, Gdc-1 | Boston Scientific Corporation | HCG | Class II |