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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K190710 | EliA SymphonyS Immunoassay | Phadia AB | LLL | Class II | |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical, Inc. | HAW | Class II | |
| K192791 | Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | |
| K192519 | Multi-modality workstation | Beijing Superlaser Technology Co., Ltd. | ONF | Class II | |
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter | Hangzhou Bever Medical Devices Co., Ltd. | GBM | Class II | |
| K192438 | Rhythmia HDxTM Mapping System | Boston Scientific Corporation | DQK | Class II | |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | LOD | Class II | |
| K192079 | EOSedge | EOS imaging | KPR | Class II | |
| K191987 | Orapeutic | Forward Science, LLC | OLR | Unclassified | |
| K191911 | 3Shape Splint Design | 3Shape A/S | PNN | Class II | |
| K191673 | Upper Arm Blood Pressure Monitor | Famidoc Technology Co., Ltd | DXN | Class II | |
| K191428 | ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | DSA | Class II | |
| K191032 | fMRI Hardware System | NordicNeuroLab AS | LNH | Class II | |
| K190955 | Hypotension Decision Assist | Directed Systems Ltd | DXG | Class II | |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | GWO | Class II | |
| K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty Limited | JWH | Class II | |
| K192946 | DePuy Corail AMT Hip Prosthesis | Depuy Orthopaedics Inc. | LZO | Class II | |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | LIT | Class II | |
| K192764 | NeuroOne Cortical Electrode | Neuroone, Inc. | GYC | Class II | |
| K192745 | DePuy Synthes Trauma Screws | Synthes (USA) Products, LLC / Depuy Orthopaedics, Inc. | HWC | Class II | |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | bioMerieux, Inc. | JWY | Class II | |
| K192417 | ARIX Cannulated Screw System | Jeil Medical Corporation | HWC | Class II | |
| K192396 | Streamline MIS Spinal Fixation System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | Class II | |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | DiaSorin Molecular LLC | PGI | Class II | |
| K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | EOQ | Class II | |
| K192320 | HealthCXR | Zebra Medical Vision, Ltd. | QFM | Class II | |
| K192271 | Access PCT, Access PCT Calibrators | Siemens Healthcare Diagnostics Inc. | PTF | Class II | |
| K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | MAX | Class II | |
| K191961 | OrthoGold | Tissue Regeneration Technologies | PZL | Class II | |
| K191502 | Heraeus Peripheral Guidewire | Heraeus Medical Components, LLC | DQX | Class II | |
| K191426 | FiberTak Button | Arthrex GmbH | MBI | Class II | |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate S.p.A. | JWH | Class II | |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | EGS | Class I | |
| K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics Inc. | JFT | Class II | |
| K192329 | Blue Latex Examination Powder Free Gloves | JR Engineering and Medical Technologies (M) Sdn Bhd | LYY | Class I | |
| K192248 | Cortina™ [MAX] Lumbar Cage System | Neurostructures, Inc. | MAX | Class II | |
| K191851 | Vs3-Ir | Medtronic, Inc. | OWN | Class II | |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | Allwin Medical Devices, Inc. | MQE | Class II | |
| K190529 | Sozo | Impedimed, Inc. | QJB | Class II | |
| K190494 | Infant Incubator | Ningbo David Medical Device Co., Ltd. | FMZ | Class II | |
| K181845 | Pivot System Sterilization case | RP Medical Inc. | KCT | Class II | |
| K190760 | Cadwell Bolt Software | Cadwell Industries Inc | OLT | Class II | |
| K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | NTK | Class II | |
| K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | JPA | Class II | |
| K193036 | C2 CryoBalloon EndoGrip | Pentax Medical, A Division of Pentax of America, Inc. | OCX | Class II | |
| K193031 | Expd 4343P, Expd 3643P | DRTECH Corporation | MQB | Class II | |
| K193017 | Evs 4343W / Evs 4343Wg / Evs 4343Wp / Evs 3643W / Evs 3643Wg / Evs 3643Wp | DRTECH Corporation | MQB | Class II | |
| K192964 | Parcus Synd-EZ SS | Parcus Medical, L.L.C. | MBI | Class II | |
| K192877 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II |