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 |
|---|---|---|---|---|---|
| K240093 | IPL Home Use Hair Removal Device (SJ15) | Shenzhen Shuge Medical Beauty Devices Co., Ltd. | OHT | Class II | |
| K234056 | canturio® se (Canturio Smart Extension) | Canary Medical USA LLC | QPP | Class II | |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads | Howmedica Osteonics Corp., dba Stryker Orthopaedics | LZO | Class II | |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K233172 | NextAR™ Spine Platform | Medacta International SA | SBF | Class II | |
| K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) | Hebei JT Medical Co.,Ltd | NGX | Class II | |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | |
| K240816 | MeDioStar | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K240518 | swiftPro™ System | Emblation Limited | NEY | Class II | |
| K240058 | Aeye-Ds | Aeye Health Inc. | PIB | Class II | |
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) | Microline Surgical, Inc | GEI | Class II | |
| K234107 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Abbott Medical | KLA | Class II | |
| K233948 | Provisio™ SLT IVUS™ System | Provisio Medical Inc. | OBJ | Class II | |
| K233849 | Btl-499 | BTL Industries, Inc | GEI | Class II | |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Medical | QBJ | Class II | |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Head Quarters | NRY | Class II | |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2Bones SAS | HSN | Class II | |
| K222958 | mJOULE RF System and Accessories | Sciton, Inc. | GEI | Class II | |
| K240182 | Access EPO | Siemens Healthcare Diagnostics Inc. | GGT | Class II | |
| K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea SAS | MUJ | Class II | |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) | Andon Health Co., Ltd | DXN | Class II | |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | OVD | Class II | |
| K233582 | Rapid | Ischemaview, Inc. | LLZ | Class II | |
| K233311 | Acumed Wrist Plating System | Acumed LLC | HRS | Class II | |
| K232319 | Black Pearl Nitrile Examination Glove | UG Global Resources Sdn Bhd | LZA | Class I | |
| K223515 | MamaLift Plus | Curio Digital Therapeutics | SAP | Class II | |
| K232149 | BowTie™ SI Joint Fusion System | Sail Fusion | OUR | Class II | |
| K240781 | SKOUT® system | Iterative Scopes, Inc. | QNP | Class II | |
| K240753 | Miro3D Fibers Wound Matrix | Reprise Biomedical, Inc. | KGN | Unclassified | |
| K240534 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | QHW | Class II | |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. | LFD | Unclassified | |
| K240378 | Faq™ 201, Faq™ 202 | Foreo Inc | OHS | Class II | |
| K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control | MPD | Class II | |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | OVE | Class II | |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | GWF | Class II | |
| K234073 | ICE Aspiration System | Expanse Medical Inc. | QEW | Class II | |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | IZQ | Class II | |
| K233373 | Flowflex® Plus COVID-19 Home Test | Acon Laboratories, Inc. | QYT | Class II | |
| K233106 | AccuCath Ace™ Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | FOZ | Class II | |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | GZJ | Class II | |
| K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | MHX | Class II | |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | SeaSpine Orthopedics Corporation | NKB | Class II | |
| K232377 | Healgen Rapid COVID-19 Antigen Test | Healgen Scientific LLC | QVF | Class II | |
| K232259 | Patriot-SI Posterior Implant System | Spinal Simplicity, LLC | OUR | Class II | |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | QSY | Unclassified | |
| K232204 | ReyaGel (RG03 - MTP gel 3mL) | Fettech | KGN | Unclassified | |
| K232105 | APTUS Foot System 2.8-3.5 | Medartis AG | HRS | Class II | |
| K230120 | KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. | JWH | Class II | |
| K240258 | Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. | FXX | Class II |