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 |
|---|---|---|---|---|---|
| K143728 | Minhua Disposable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus | DXQ | Class II | |
| K143694 | Rhondium One-Visit-Crown(OVC) | Rhondium Limited | EBF | Class II | |
| K143643 | Brainscope Ahead 200 | Brainscope | PIW | Class II | |
| K143294 | Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways | Toshibamedical Systems Corporation | JAK | Class II | |
| K143242 | Rebel 3DKNEE System | Encore Medical, LP | JWH | Class II | |
| K142729 | Chi Lites Orthodontic Sapphire Bracket | Progressive Technology, Inc. | NJM | Class II | |
| K142516 | Propeller System | Reciprocal Labs Corporation | CAF | Class II | |
| K141883 | Cliniscansm EEG | Picofemto, LLC | OMB | Class II | |
| K141168 | Ansistim | Dyansys, Inc. | BWK | Unclassified | |
| K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere | Exactech, Inc. | PHX | Class II | |
| K150171 | Tinnitus Sound Generator Module | GN Resound A/S | KLW | Class II | |
| K143435 | Planmed Verity | Planmed Oy | OAS | Class II | |
| K143326 | T.A.G. Dental Implant System | T.A.G. Medical Products Corporation Ltd | DZE | Class II | |
| K143078 | Bookwalter Gordon Adjustable Compression Element | Symmetry Surgical GmbH | DXC | Class II | |
| K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | FUJIFILM Healthcare Americas Corporation | FDS | Class II | |
| K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | PKP | Class II | |
| K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | FRO | Unclassified | |
| K141057 | Disposable Cervical Brush | Ningbo HLS Medical Products Co., Ltd. | HHT | Class II | |
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 | HMD Biomedical, Inc. | NBW | Class II | |
| K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corp. | FIE | Class II | |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific LLC | JXM | Class II | |
| K150310 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | DSI | Class II | |
| K150226 | Hematocrit and Metabolite QUALICHECK | Radiometer Medical ApS | JJS | Class I | |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | SPINEFRONTIER, Inc. dba LESspine Innovations | MAX | Class II | |
| K141886 | Mdk Handpieces | Modern Korea Co., Ltd. | EFB | Class I | |
| K150970 | Coda LP Balloon Catheter | Cook Incorporated | DQY | Class II | |
| K150681 | Gemore OTC TENS | Gemore Technology Co., Ltd. | NUH | Class II | |
| K150675 | Dorsal Spanning Plate | Skeletal Dynamics, Inc | HRS | Class II | |
| K150539 | OASYS System | Stryker Corp. | NKG | Class II | |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | OXH | Class II | |
| K150224 | Blue Vinyl Gloves Powder Free | Zibo Sanying Trade Co., Ltd. | LYZ | Class I | |
| K150185 | Mont Blanc Spinal System | Spineway | NKB | Class II | |
| K150161 | Venus Viva SR Device | Venus Concept Inc. | GEI | Class II | |
| K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | OEB | Class II | |
| K150345 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard Inc | EZD | Class II | |
| K150152 | The Octane Straight Intervertebral Fusion Device, Ti Coated | Exactech, Inc. | MAX | Class II | |
| K150126 | Life Spine Cannulated Screws | Life Spine | HWC | Class II | |
| K150125 | Elite Nitinol Fixation System | Biomedical Enterprises, Inc. | JDR | Class II | |
| K143647 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies, LLC | OQG | Class II | |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | Acon Laboratories, Inc. | KQO | Class I | |
| K142260 | NobelActive | Nobel Biocare AB | DZE | Class II | |
| K142055 | Gymform ABS & Core | Well Brain International, Ltd. | NGX | Class II | |
| K150533 | Terason uSmart3200T Ultrasound System | Teratech Corp. | IYN | Class II | |
| K151007 | 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) | JVCKENWOOD Corporation | PGY | Class II | |
| K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm | Verge Medical Inc. | LIT | Class II | |
| K150816 | Jumong Series | SG Healthcare Co Ltd | KPR | Class II | |
| K150772 | Snap-Off Self-Compressive Screw | Neosteo | HWC | Class II | |
| K150706 | VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | |
| K150636 | VariSeed 9.0 | Varian Medical Systems, Inc. | KXK | Class II | |
| K150620 | 740 Select | Cas Medical Systems, Inc. | MWI | Class II |