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 |
|---|---|---|---|---|---|
| K243285 | TMINI Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K242960 | AdVance™ XP Male Sling System (720163-03) | Boston Scientific Corporation | OTM | Class II | |
| K242800 | The 5000 Compact Series Ultrasound Systems | Philips North America LLC | IYN | Class II | |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Hologic, Inc. | QOF | Class II | |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. dba Surmodics, Inc. | LIT | Class II | |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | DENT4YOU AG | ELW | Class II | |
| K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | |||
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | ODP | Class II | |
| K242130 | Koios DS | Koios Medical, Inc. | POK | Class II | |
| K242062 | 1CMR Pro | Mycardium AI Ltd | LLZ | Class II | |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno Inc. | QFM | Class II | |
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NLH | Class II | |
| K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator | LivsMed Inc. | GEI | Class II | |
| K241125 | Vivix-S 1751S | Vieworks Co., Ltd. | MQB | Class II | |
| K241070 | Gelsoft™ Plus Vascular Prostheses | Vascutek, Ltd. | DSY | Class II | |
| K240860 | EchoGo Amyloidosis (1.0) | Ultromics, Ltd. | SDJ | Class II | |
| K240528 | b-ONE® Total Hip System | b-ONE Ortho Corp. | LZO | Class II | |
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | Shenzhen VitaVitro Biotech Co.,Ltd. | MQE | Class II | |
| K233081 | NUVENTUS NV.C™ Dental Implant System | Infinitum Eta Ltd. | DZE | Class II | |
| K242940 | Xrecovery (XR-001) | Shenzhen Xinrun Electric Appliances Co Ltd | IRP | Class II | |
| K242814 | Tandry Q-Locking Plate System | Microware Precision Co., Ltd. | HRS | Class II | |
| K242598 | DEFINE System (AG612444A) | Inmode Ltd. | PBX | Class II | |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co.,Ltd. | ONF | Class II | |
| K242436 | Proximal Humerus Fixation System | Skeletal Dynamics, Inc | HRS | Class II | |
| K242342 | Fetal EchoScan | Brightheart | POK | Class II | |
| K242079 | Arthrex Elbow Fracture Plating System | Arthrex GmbH | HRS | Class II | |
| K241930 | Veincare | WONTECH Co., Ltd. | GEX | Class II | |
| K241397 | Hinscope | Hinlab SAS | MSX | Class II | |
| K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corporation | CAH | Class II | |
| K243273 | CeQur Simplicity™ On-Demand Insulin Delivery System | CeQur SA | OPP | Class II | |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K242764 | MediRod Pedicle Screw System | CMF Medicon Surgical Inc | NKB | Class II | |
| K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co.,Ltd | EIH | Class II | |
| K241135 | RESPOND(R) Ventilator | Corvent Medical Inc. | CBK | Class II | |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | EFB | Class I | |
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc | OLK | Class II | |
| DEN240023 | SmartFlow Neuro Cannula | ClearPoint Neuro Inc. | SDG | Class II | |
| K242791 | Electric wheelchair (KR-8807) | Zhejiang Kairui Medical Device Co., Ltd. | ITI | Class II | |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic, Inc. | NDC | Class II | |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada – Supermax Medical | FXX | Class II | |
| K242430 | Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) | Soul Mobility, Inc | ITI | Class II | |
| K242420 | pNOVUS 21 Microcatheter | Phenox Inc | DQO | Class II | |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | MEDLINE INDUSTRIES, LP - Northfield | FED | Class II | |
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | LifeSignals, Inc. | DRG | Class II | |
| K241981 | Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company | LLZ | Class II | |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | Foshan Soco Precision Instrument Co.,Ltd. | EFB | Class I | |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | MQB | Class II | |
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | Jaeger Medical GmbH | CCK | Class II | |
| DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | STERIS Corporation | SDC | Class II | |
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | Straumann USA, LLC | NHA | Class II |