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 |
|---|---|---|---|---|---|
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. | IRP | Class II | |
| K244026 | PAL 7020 Console | MicroAire Surgical Instruments, LLC | QPB | Class II | |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | KDN | Class II | |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | JOJ | Class II | |
| K243861 | butterflyBVM | Compact Medical Inc. | BTM | Class II | |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | CareFusion 303, Inc | FRN | Class II | |
| K243821 | i-Cut | A.M.I. Agency for Medical Innovations GmbH | HET | Class II | |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd | FRG | Class II | |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems Inc | QOF | Class II | |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems Inc | QOF | Class II | |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | Corcym Inc. | KDI | Class II | |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | FLL | Class II | |
| K243041 | contact forte Alpha | BHM-Tech Produktionsgesellschaft mbH | LXB | Class II | |
| K242469 | RFMagik Lite | Agnes Medical Co.,Ltd | GEI | Class II | |
| K242321 | Kosmos | Echonous Inc | IYN | Class II | |
| K250262 | Go-Pen® | Go-Pen ApS | FMF | Class II | |
| K250206 | Diode laser system (Night Universe; Predator) | Ivylaser (Beijing) Technology Co., Ltd. | GEX | Class II | |
| K250183 | CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. | GEX | Class II | |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K250002 | Smart Check O2 (MA0236) | Life Spark Medical | CCL | Class II | |
| K243954 | PeriCross™ Epicardial Access Kit | CIRCA Scientific, Inc. | DYB | Class II | |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | Surgentec LLC | KNW | Class II | |
| K243714 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K243239 | Lung AI (LAI001) | Exo, Inc. | MYN | Class II | |
| K242973 | CanMINI Hand and Foot System | Canwell Medical Co., Ltd. | HRS | Class II | |
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | LCJ | Unclassified | |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd | EKX | Class I | |
| K242214 | Sonu | Sound Health Systems, Inc. | QZC | Class II | |
| K233337 | Freespira Breathing System | Freespira, Inc | SEN | Class II | |
| K250944 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl | GMP Medicare Sdn Bhd | LZA | Class I | |
| K250869 | Parietene™ Macroporous Mesh (PPM5050 ) | Sofradim Production | FTL | Class II | |
| K250831 | Annalise Enterprise | Annalise-Ai Pty, Ltd. | QFM | Class II | |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd | BTA | Class II | |
| K250228 | eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) | Esonic Technology (Wuhan) Co., Ltd. | IYN | Class II | |
| K250198 | Laon Ortho | Laon Medi Inc. | PNN | Class II | |
| K250155 | Xpert Knee | Newclip Technics | HRS | Class II | |
| K243697 | MySpine WebPlanner | Medacta International SA | LLZ | Class II | |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | IYO | Class II | |
| K243326 | Dynamis Robotic Surgical System | Lem Surgical Inc | OLO | Class II | |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | Hycor Biomedical | DHB | Class II | |
| K242232 | Mpact 3D Metal Augments II | Medacta International SA | LPH | Class II | |
| K250669 | Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | PNO | Class II | |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | EBG | Class II | |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | OVD | Class II | |
| K243343 | Bd Ctgctv2 | BD Integrated Diagnostic Solutions/Becton | QEP | Class II | |
| K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | NHA | Class II | |
| K242247 | ARIX Femur Nail System | Jeil Medical Corporation | HSB | Class II | |
| K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | MYC | Class II |