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 |
|---|---|---|---|---|---|
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International Co. | FMF | Class II | |
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | iHealth Labs, Inc. | SCA | Class II | |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | JOW | Class II | |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | FUJIFILM Corporation | EOQ | Class II | |
| K250847 | VaporShield | Vault Paragon Group, Inc. | MEG | Class II | |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.r.l. | DTZ | Class II | |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | NUC | Class II | |
| K242817 | Jason membrane | Botiss Biomaterials GmbH | NPL | Class II | |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | OVE | Class II | |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | DQK | Class II | |
| K252997 | HyperFlex® Bunion Correction System | HyperFlex Medical Inc | HRS | Class II | |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | FXX | Class II | |
| K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista | A Plus Biotechnology Co., Ltd. | HRS | Class II | |
| K252694 | Target Detachable Coil | Stryker Corp. | HCG | Class II | |
| K252482 | CogNet AI-MT+ | Medcognetics, Inc | QFM | Class II | |
| K251883 | MIM – LesionID Pro | MIM Software Inc | LLZ | Class II | |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | HRS | Class II | |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | HSB | Class II | |
| K252497 | Sansa Hsat | Huxley Medical | MNR | Class II | |
| K251598 | Intellidrop | BRAINSPACE Inc | JXG | Class II | |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co.,Ltd. | FMF | Class II | |
| K253706 | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corp. | EMA | Class II | |
| K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona Inc | NHA | Class II | |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | NGX | Class II | |
| K251199 | Allia Moveo | GE Medical Systems SCS | OWB | Class II | |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Sunrise Medical, Inc. | CAW | Class II | |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | GEH | Class II | |
| K243449 | Infinitt Dps | Infinitt Healthcare Co., Ltd. | QKQ | Class II | |
| K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) | Guangdong Ace-Tec Co., Ltd. | OHS | Class II | |
| K252862 | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co.,Ltd. | ITI | Class II | |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | EIH | Class II | |
| K252294 | Fetal EchoScan (v1.2) | Brightheart | POK | Class II | |
| K251936 | Ceribell Delirium Monitor System | Ceribell, Inc. | NCG | Class II | |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | OVD | Class II | |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam | DXH | Class II | |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co., Ltd. | JOW | Class II | |
| K253868 | QuietLab Pro | QuietLab LLC | LRK | Class II | |
| K252841 | Real Intelligence™ Cori™ Xt (Cori Xt) | Blue Belt Technologies, Inc. | OLO | Class II | |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | IOR | Class I | |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | IOR | Class I | |
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | FFX | Class II | |
| K252504 | Gastric Alimetry | Alimetry Ltd | MYE | Class II | |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) | Sonoscape Medical Corp. | IYN | Class II | |
| K252494 | Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co.,Ltd. | ITI | Class II | |
| K252465 | Any-Core | Mediclus Co., Ltd | EBF | Class II | |
| K252296 | OncoPatch | Oncopatch, Inc. | KXK | Class II | |
| K252151 | els unibond | Saremco Dental AG | KLE | Class II | |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | OHS | Class II | |
| K252067 | Velora Acetabular System | restor3d, Inc. | LPH | Class II |