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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K143288 | Sensititre Susceptibility plates | Thermo Fisher Scientific Oy | JWY | Class II | |
| K142745 | 125mL CT Syringe | Coeur, Inc. | DXT | Class II | |
| K141997 | Crit-Line IV System | Fresenius Medical Care | KOC | Class II | |
| DEN140030 | SpaceOAR System | Augmenix, Inc. | OVB | Class II | |
| K150527 | Xcela Power Injectable PICC | Boston Scientific Corporation | LJS | Class II | |
| K150325 | Range/Denali/Mesa Spinal System | K2M, Inc | NKB | Class II | |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | Myriad Medical LLC | PCT | Class II | |
| K150175 | HeatLux Pro I | Home Skinovations, Ltd. | ILY | Class II | |
| K143567 | NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) | Marvao Medical Devices Ltd. | MSD | Class II | |
| K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw | Zimmer GmbH | HWC | Class II | |
| K142818 | Phasix Mesh | Bard Access Systems, Inc. | OOD | Class II | |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | Immco Diagnostics, Inc. | LLL | Class II | |
| K142723 | ADVIA Centaur Cortisol (COR) Assy | Siemens Healthcare Diagnostics Inc. | JFT | Class II | |
| K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | ODP | Class II | |
| K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use Sp | Olympus Medical Systems Copr. | KNS | Class II | |
| K141785 | Micro Thermx Microwave Ablation System and Accessories | Bsd Medical Corp. | NEY | Class II | |
| K141757 | Alere I Strep a | Alere Scarborough, Inc. | PGX | Class II | |
| K141181 | Nuve for Wrinkles, Dpl Nuve for Wrinkles | LED Technologies, Inc. | OHS | Class II | |
| K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | OXC | Class II | |
| K150529 | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System | C.R. Bard Inc | IYO | Class II | |
| K143697 | Biomet Proximal Humerus Plating System | Biomet Manufacturing Corp | HRS | Class II | |
| K143695 | Central Monitoring System | Edan Instruments, Inc. | HGM | Class II | |
| K143365 | Eminent Foot Plate System | Eminent Spine | HRS | Class II | |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems Ltd. | JJX | Class I | |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | Natec Medical Ltd | LIT | Class II | |
| K141527 | Depuy Synthes Variable Angle Locking Hand System | Synthes (USA) Products LLC | HRS | Class II | |
| K150192 | Scenium | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K143032 | eMotion Faros ECG Mobile | Mega Electronics, Ltd. | DXH | Class II | |
| K150366 | SOFIA 6F Catheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K150291 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | FTL | Class II | |
| K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector | Rayence Co., Ltd. | MQB | Class II | |
| K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | PDQ | Class II | |
| K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter | Olympus Surgical Technologies America | FGE | Class II | |
| K143517 | Voyant Open Sealer-Divider Device | Applied Medical Resources Corp | GEI | Class II | |
| K143180 | F3 | Permobil, AB | ITI | Class II | |
| K143108 | HealthGuard-15 | Futrex, Inc. | DXN | Class II | |
| K142709 | samaritan PAD 450P | HeartSine Technologies Ltd | MKJ | Class III | |
| K142677 | MALDI Biotyper CA System | Bruker Daltonics | PEX | Class II | |
| K142426 | EBI External Implant System | Ebi, Inc. | DZE | Class II | |
| K142420 | Patient Positioning Devices | Macromedics BV | IYE | Class II | |
| K141385 | Depuy Synthes Injectable Polymer System (Ips) | Depuy Synthes Companies of Johnson & Johnson | HBW | Class II | |
| K141322 | Advance Enforcer 35 Focal Force Pta Balloon Catheter | Cook Incorporated | PNO | Class II | |
| K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | Westtec, LLC | FXX | Class II | |
| K140110 | Flextip Plus Epidural Catheter;flexblock Continous Peripheral Nerve Block Catheter Kit/set | Teleflex Medical | BSO | Class II | |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | EWO | Class II | |
| K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | DXT | Class II | |
| K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K150196 | DD cubeX2 | Dental Direkt GmbH | EIH | Class II | |
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | Trividia Health, Inc. | NBW | Class II | |
| K143409 | SOMATOM Definition AS Open (VA48) | Siemens Medical Solutions USA, Inc. | JAK | Class II |