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 |
|---|---|---|---|---|---|
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | |
| K241355 | SER Pen Carain MicroSystem (MP1209SP) | SU-KO Technologies LLC | QAI | Class II | |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | PBX | Class II | |
| K240181 | Clavicle and Scapula System | Auxein Medical Pvt., Ltd. | HRS | Class II | |
| K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care Us Medical Product Co., Ltd. | LRX | Class II | |
| K231948 | Mediyag | Medicreations LLC | GEX | Class II | |
| K242826 | ProLift Wedge Expandable Spacer System | Life Spine | MAX | Class II | |
| K242391 | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Lucens Technology Co., Ltd. | LPL | Class II | |
| K242267 | Gemini Medical Cage System | Zhejiang Decans Medical Devices Co.,Ltd. | MAX | Class II | |
| K242014 | Jet Flow Bulk | Meta Biomed Co., Ltd. | EBF | Class II | |
| K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics Ltd. | QGT | Class II | |
| K241446 | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. | IRP | Class II | |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | NBW | Class II | |
| K240563 | Power Wheelchair (JJW-6001) | Zhejiang J&J Mobility Co., Ltd | ITI | Class II | |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | MOL | Class II | |
| K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | FED | Class II | |
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | Omron Healthcare Co., Ltd. | QXY | Class II | |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | HSX | Class II | |
| K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research & Development Corp. | LDR | Class II | |
| K242457 | EARP Interbody System | Retropsoas Technologies, LLC | MAX | Class II | |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | LPH | Class II | |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corp. | OCX | Class II | |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products Inc. | FRG | Class II | |
| K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte., Ltd. | MEB | Class II | |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | LPH | Class II | |
| K241029 | SpineUs™ System | Verdure Imaging Inc | IYO | Class II | |
| K240980 | EPIQ Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K240843 | Genesis (Ms-P02-Gen) | Climbing Steps Inc | ILK | Class II | |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen | SCA | Class II | |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | Stryker Corp. | HRS | Class II | |
| K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | Shenzhen Finicare Co., Ltd. | DXN | Class II | |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | Fengh Medical Co., Ltd. | GDW | Class II | |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | HWC | Class II | |
| K242652 | Lunit INSIGHT DBT v1.1 | Lunit Inc. | QDQ | Class II | |
| K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical Inc. | HAW | Class II | |
| K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | HRS | Class II | |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | FDF | Class II | |
| K242106 | AuST Steerable Sheath | Centerpoint Systems LLC | DYB | Class II | |
| K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader | Vivachek Biotech (Hangzhou) Co., Ltd | NGL | Class II | |
| K241854 | Power Wheelchair | Anhui JBH Medical Apparatus Co., Ltd | ITI | Class II | |
| K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | Trocare, LLC | GCJ | Class II | |
| K241746 | Umed Reprocessed Aircast Venaflow Foot Cuff; Umed Reprocessed Kendall Scd Express Sleeve; Umed Reprocessed Aircast Elite Calf Cuff 3040 3050; Umed Reprocessed Ctc Vp 501 Calf Cuff; Umed Reprocessed Ctc Vp 520 Foot Cuff | United Medical Resources LLC | JOW | Class II | |
| K241434 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | |
| K241298 | Quadsense | Eventum Orthopaedics Ltd | ONN | Class II | |
| K241245 | EchoSolv AS | Echo IQ, Ltd. | POK | Class II | |
| K241052 | Bladeless Trocar; Bladed Trocar; Hasson Trocar | Advamedix, GmbH | GCJ | Class II | |
| K240675 | Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co.,Ltd. | FBK | Class II | |
| K240553 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II |