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 |
|---|---|---|---|---|---|
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation | MAX | Class II | |
| K243683 | Deka Bluebeam | El.En S.p.A. | GEX | Class II | |
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | JDS | Class II | |
| K243234 | Second Opinion® CS | Pearl, Inc. | MYN | Class II | |
| K242872 | iDart Lyme IgM ImmunoBlot Kit | ID-Fish Technology, Inc | LSR | Class II | |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. | KWL | Class II | |
| DEN240032 | APO-Easy Genotyping kit | Firalis S.A. | SFC | Class II | |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) | William Cook Europe ApS | BTR | Class II | |
| K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | Bonebridge AG | HRS | Class II | |
| K250787 | Liberant Thrombectomy System | Medtronic Ireland | QEW | Class II | |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | KIF | Class II | |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc | HTY | Class II | |
| K250584 | Rezum System | Boston Scientific Corporation | KNS | Class II | |
| K250269 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) | Ambu A/S | FAJ | Class II | |
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows | SAH | Class II | |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology Inc | HQC | Class II | |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | NAY | Class II | |
| K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics GmbH | QVP | Class II | |
| K250735 | Dental Barrier and Sleeves | Fomed Industries Inc | PEM | Class II | |
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Viz. Ai, Inc. | QIH | Class II | |
| K250010 | Extron 3; Extron 5; Extron 7 | DRTECH Corporation | OWB | Class II | |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corp. | CCK | Class II | |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | FUJIFILM Corporation | FDS | Class II | |
| K242996 | EndyMed PRO MAX | Endymed Medical Inc. | GEI | Class II | |
| K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm | Vitaltec Corporation | BTO | Class II | |
| K251500 | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | QOG | Class II | |
| K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | FRO | Unclassified | |
| K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | Shenzhen Sungrow LED Technology Co.,Ltd | OHS | Class II | |
| K250465 | CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co.,Ltd. | GEX | Class II | |
| K250746 | Magnetic Surgical System | Levita Magnetics International Corp. | PNL | Class II | |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | SI-Technology, LLC | OUR | Class II | |
| K251452 | 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 | |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | Shenzhen Desida Technology Co., Ltd. | BTA | Class II | |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd | EBF | Class II | |
| K251131 | Annex® 2 Adjacent Level System | Spine Wave Inc | NKB | Class II | |
| K251042 | Light Therapy System (M500, L6) | Guangzhou Ahead Intelligent Technology Co., Ltd. | OHS | Class II | |
| K251009 | Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. | QIH | Class II | |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | ConvaTec Limited | FCM | Class II | |
| K250722 | Nd: YAG Laser Therapy System (QN-1) | Hebei JT Medical Co.,Ltd | GEX | Class II | |
| K250591 | Anovo Surgical System (6Ne) | Momentis Surgical Ltd. | QNM | Class II | |
| K250321 | GCI Sterilization Wrappers | George Courey Inc | FRG | Class II | |
| K250109 | TYBR Collagen Gel | Tybr Health, Inc. | OWY | Class II | |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | FLE | Class II | |
| K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue | Mah Sing Healthcare Sdn Bhd | LZA | Class I | |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & Co. KG | FGB | Class II | |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | Luminex Corporation | PAM | Class II | |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | LPH | Class II | |
| K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | DZE | Class II | |
| K242907 | DELPHI System | CnS MEDICAL CO., Ltd. | GEI | Class II | |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical Ltd | KNS | Class II |