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 |
|---|---|---|---|---|---|
| K243534 | Micro Catheter | Suzhou Zenith Vascular Scitech Limited | KRA | Class II | |
| K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. | LPL | Class II | |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | HRX | Class II | |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corp. | KTI | Class II | |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | DRT | Class II | |
| K251350 | BD Plastipak™ Syringe | Becton Dickinson & Co | FMF | Class II | |
| K250647 | SImmetry+ System | Sivantage | OUR | Class II | |
| K250442 | da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. | NAY | Class II | |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | DSI | Class II | |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | MHX | Class II | |
| K243473 | Prorad Atlas Ultraportable; Prorad Atlas Ultraportable Plus | Prognosys Medical Systems Private Limited | IZL | Class II | |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | KNW | Class II | |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | FRN | Class II | |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | FRN | Class II | |
| K251220 | NUVENTUS NV.C™ Prosthetic Components | Infinitum Eta Ltd. | NHA | Class II | |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd | NUH | Class II | |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana Inc. | QYE | Class II | |
| K243489 | Alinity m EBV (09N43-095) | Abbott Molecular, Inc. | QLX | Class II | |
| K241183 | ISO Abutment | Seum Medi Co., Ltd. | NHA | Class II | |
| K252215 | InbellaMAX System | Inbella Medical Inc. | GEI | Class II | |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health Pte. Ltd. | FMF | Class II | |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., dba Stryker Orthopaedics | KRO | Class II | |
| K251620 | A.L.P.S. Proximal Humerus Plating System | Zimmer GmbH | HRS | Class II | |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | Zhengzhou PZ Laser Slim Technology Co., Ltd | GEX | Class II | |
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | GE Healthcare | IYN | Class II | |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp., dba Stryker Orthopaedics | LPH | Class II | |
| K250970 | Marie | Leo Cancer Care Ltd. | JAK | Class II | |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee BioMedical, Inc. | KRH | Class II | |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | Abbott Medical | DQX | Class II | |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | GWO | Class II | |
| K250244 | Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. | IRP | Class II | |
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | |
| K243403 | BD Nexiva™ Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | BZE | Class II | |
| K252056 | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | OCL | Class II | |
| K252010 | SPY Laparoscope | Stryker Corp. | GCJ | Class II | |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | KQJ | Class II | |
| K251955 | Onflex™ Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL | Class II | |
| K251618 | MOTO Partial Knee System Extension | Medacta International SA | HSX | Class II | |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona Inc | DZE | Class II | |
| K250322 | Respond OC Conserving Regulator (130-0800) | Responsive Respiratory Inc. | NFB | Class II | |
| K250284 | TSK SELECT™ Needle | TSK Laboratory, Japan | FMI | Class II | |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | Wuxi Hisky Medical Technologies Co., Ltd. | OWN | Class II | |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | FPA | Class II | |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | NEU | Class II | |
| K251280 | DESS® Dental Implants | Terrats Medical, S.L. | DZE | Class II |