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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K152863 | Portable ECG Monitor | Contec Medical Systems Co., Ltd. | DPS | Class II | |
| K161444 | DBSWIN and VistaEasy Imaging Software | Duerr Dental AG | LLZ | Class II | |
| K160691 | Acne Light Therapy Wand | Zuko, Inc. | OLP | Class II | |
| K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys SAS | LLZ | Class II | |
| K160213 | s-Clean Tapered II RBM Implant System | Dentis Co.,Ltd | DZE | Class II | |
| K160209 | Gold Anchor | Naslund Medical Inc. | IYE | Class II | |
| K160131 | OEC Elite MiniView | GE Hangwei Medical Systems, Co. Ltd | OXO | Class II | |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | Teleflex Medical | CAZ | Class II | |
| K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | MWI | Class II | |
| K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K152246 | Aquarius Stoma Measuring Device | Degania Silicone, Inc. | KNT | Class II | |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator | Apyx Medical Corporation | GEI | Class II | |
| K160598 | REBOA Balloon Catheter | Numed Inc | MJN | Class II | |
| K160525 | Rct700 | Ray Co., Ltd. | OAS | Class II | |
| K160458 | Bi Image-X Evolution | Radiotecnologia Industrial S.A. de C.V. | EHD | Class II | |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... | Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP | Class II | |
| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical Inc. | FFX | Class II | |
| K152884 | DermaTherapy Bed Linens | Precision Fabrics Group, Inc. | FMW | Class I | |
| K152244 | RADspeed Pro | Shimadzu Corp. | KPR | Class II | |
| K152734 | Kerrison Rongeurs | Vitalitec Medizintechnik GmbH | HAE | Class II | |
| K161364 | BinaxNOW G6PD Test | Alere Scarborough, Inc. | JBF | Class II | |
| K161280 | Cervical Stand Alone System | Orthofix SRL | OVE | Class II | |
| K161045 | Monoject | Medtronic, Inc. | PNR | Class II | |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | Halyard Health | PNR | Class II | |
| K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector | Boston Scientific Corporation | PIF | Class II | |
| K160681 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | DQY | Class II | |
| K160544 | Withings Thermo (Model SCT01) | Withings | FLL | Class II | |
| K160265 | Image Navigator by Immuno Concepts | IMMUNO CONCEPTS, NA, Ltd. | DHN | Class II | |
| K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | |
| K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System | Orthocare | HRS | Class II | |
| K153367 | S698 Symbioz flow | Sopro - Acteon Group | HIF | Class II | |
| K153351 | Quantib Brain 1 | Quantib B.V. | LLZ | Class II | |
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long | Sumitomo Bakelite Co., Ltd. | KNS | Class II | |
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | The Binding Site Group Ltd. | OPX | Class II | |
| K160795 | United Urologics Intermittent Catheter | Robling Medical, LLC | GBM | Class II | |
| K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences LLC | DQE | Class II | |
| K160350 | ECG CT Gating Device | NeoCoil, LLC | JAK | Class II | |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Zimmer GmbH | MBB | Class II | |
| K153632 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | FTL | Class II | |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | LXB | Class II | |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL | Teleflexmedical, Inc. | GAT | Class II | |
| K161346 | NormaTec PCD-T and PCD-B | Normatec Industries, LP | JOW | Class II | |
| K161342 | Sonic Window | Analogic Corp. | IYO | Class II | |
| K160821 | Tria Sapphire | Tria Beauty, Inc. | OLP | Class II | |
| K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | HSX | Class II | |
| K160539 | BiZact Open Sealer/Divider | Medtronic, Inc. | GEI | Class II | |
| K160498 | Dentivera Milling Disc | Dental Solutions, Inc. | EBI | Class II | |
| K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control | Abbott Medical | LIP | Class II | |
| K153607 | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics GmbH | ONX | Class II | |
| K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | FXX | Class II |