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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K243188 | Cylox® St | Signus Medizintechnik GmbH | OVE | Class II | |
| K243155 | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) | Dongguan ZSR Biomedical Technology Company Limited | FGB | Class II | |
| K241897 | Mor | Morari, Inc. | QRC | Class II | |
| K241817 | InSet Total Shoulder System | SHOULDER INNOVATIONS, Inc | KWT | Class II | |
| K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd | DXN | Class II | |
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical Ltd. | DZE | Class II | |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated | BTR | Class II | |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Roche Molecular Systems Inc | QQX | Class II | |
| K244042 | Calcium2 | Abbott Ireland | CJY | Class II | |
| K243516 | Remi Custom Night Guard | Grindguard Inc | MQC | Unclassified | |
| K243511 | OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd | NGX | Class II | |
| K243453 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | OHT | Class II | |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | NFO | Class II | |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K241659 | Ultrasound Workspace (UWS 6.0) | Philips North America LLC | QIH | Class II | |
| K241516 | Btl-398 | BTL Industries, Inc | KPI | Class II | |
| K240958 | Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. | HRS | Class II | |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | Assure Tech LLC | NFT | Class II | |
| K243780 | HELIOS 785 Pico (1754V2) | Laseroptek | GEX | Class II | |
| K243661 | Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. | DXN | Class II | |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co.,Ltd. | FET | Class II | |
| K242957 | Identify (4.0) | Varian Medical Systems, Inc. | IYE | Class II | |
| K242713 | Any-Com Bulk | Mediclus Co., Ltd | EBF | Class II | |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | OVE | Class II | |
| K242404 | BDC Dental Unit | Bdc Dental Corporation, Ltd. | EIA | Class I | |
| K242368 | Symani Surgical System | Medical Microinstruments, Inc. | SAQ | Class II | |
| K241483 | ceramys™ femoral head system | Encore Medical, LP | LZO | Class II | |
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics GmbH | QWH | Class II | |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation | PKL | Class II | |
| K250061 | Celerity Incubator | STERIS Corporation | FRC | Class II | |
| K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. | HRS | Class II | |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | STERIS Corporation | FRC | Class II | |
| K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | Ever Global (Vietnam) Enterprise Corporation | LZA | Class I | |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert | Howmedica Osteonics Corp., dba Stryker Orthopaedics | JWH | Class II | |
| K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., dba Stryker Orthopaedics | LPH | Class II | |
| K243488 | Vmat Pro | Termosalud | ISA | Class I | |
| K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) | Guangzhou Chuang Zao Mei Technology Co., Ltd. | GEX | Class II | |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience | GXY | Class II | |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co Ltd | FTC | Class II | |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) | Unimed Medical Supplies Inc | DQA | Class II | |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Guangzhou Decheng Biotechnology Co., Ltd. | NGL | Class II | |
| K242324 | Dutau-Novatech® | Novatech S.A. | EOQ | Class II | |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | KNS | Class II | |
| K242111 | Vivace | Unimom.Co | HGX | Class II | |
| K241702 | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty, Ltd. | HRS | Class II | |
| K243790 | GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor | DePuy Mitek, Inc. | MAI | Class II | |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | Surgentec LLC | FMF | Class II |