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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K010257 | Zoll M Series | ZOLL Medical Corporation | MKJ | Class III | |
| K010250 | Tetric Ceram Hb | Ivoclar North America, Inc. | EBF | Class II | |
| K010111 | Cardioimmune Tl Cardiac Marker Control Levels 1, 2, 3, and Multi-Pack | Medical Analysis Systems, Inc. | JJY | Class I | |
| K010109 | Fluoroperm 151-Ok, Paragon Hds 100-Ok | Paragon Vision Sciences, Inc. | MUW | Class II | |
| K010077 | Health-Plus, Sanitex, Reliance Powder-Free Nitrile Examination Gloves | Pwa Industries Sdn. Bhd. | LZA | Class I | |
| K003963 | Dimension Psa Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | LTJ | Class II | |
| K003865 | Cobas Integra Amphetamines | Roche Diagnostics GmbH | DKZ | Class II | |
| K003801 | Anatomical Press-Fit Humeral Stem | Sulzer Orthopedics, Inc. | KWS | Class II | |
| K003762 | Ali 3D Tool Module for Medical Images | A.L.I. Technologies, Inc. | LLZ | Class II | |
| K003719 | Vascular Architects Periscope Device | Vascular Architects, Inc. | DWX | Class II | |
| K002827 | Mac Acupuncture Needle | Haenglim Seowon Corp. | MQX | Class II | |
| K010502 | Model Thermo Tek Quickcare | Saat, Ltd. | FLL | Class II | |
| K010386 | Duo-Dent Dental Implant | Duo-Dent Dental Implant Systems, LLC | DZE | Class II | |
| K010267 | Palfique Estelite Lv Clear | Tokuyama America Inc. | EBF | Class II | |
| K010059 | Engplus | Western Systems Research, Inc. | GWN | Class II | |
| K003946 | Signa Sp 0.5T Rotating Horizontal Body Coil | GE Healthcare | MOS | Class II | |
| K003868 | Sensititre Susceptibility Plates-Additional Antimicrobics | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K003786 | Smf Resorbable Meshes and Sheets | Synthes (USA) Products LLC | JEY | Class II | |
| K003699 | Medivision Igs System | Medivision (U.S.A.), Inc. | HAW | Class II | |
| K003102 | Pare Endoscopic Suturing System | Pare Surgical, Inc. | OCW | Class II | |
| K002666 | Diamond Aloe Vera, Sterile | Medi-Tech Intl. Corp. | MGQ | Unclassified | |
| K001744 | Olympus Endoscopic Ligation Device | OLYMPUS Corporation of the Americas | MND | Class II | |
| K010249 | Cd Horizon Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K010198 | Sterile Powdered Latex Surgeon Gloves | Supermax Glove Manufacturing Sdn Bhd | KGO | Class I | |
| K010148 | Ena Screen Eia Kit | The Binding Site | LLL | Class II | |
| K010021 | Medcomp Quad Lumen, 8.5F X 20Cm, Model Mc4l-8S | Medical Components, Inc. | FOZ | Class II | |
| K003834 | Sensititre Susceptibility Plates-Additional Antimicrobics | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K003776 | Microtargeting Drive System | FHC, Inc. | HAW | Class II | |
| K003749 | 100% 30G Polypropylene Spunbond Islation Grown | Banta Healthcare | FYC | Class II | |
| K003684 | Percussiveneb, Model Pn-2001 | Vortran Medical Technology 1, Inc | NHJ | Class II | |
| K003665 | Fadassi Medical Fm-1 No Blender | Fadasis Medical, Inc. | MRO | Class II | |
| K003649 | Triton Hip System | Hayes Medical, Inc. | LWJ | Class II | |
| K003648 | Freedland Tension System | Etzem Technologies, Inc. | MBI | Class II | |
| K003347 | Orthopilot | Kinamed Inc | HAW | Class II | |
| K002756 | Ease-a-Cult | Diagnostica, Inc. | KHE | Class II | |
| K000581 | Maeda New Needle Disposable | Maeda Toyokichi Shoten | MQX | Class II | |
| K010214 | Firstsave Biphasic Model #9200 and 9210 | Survivalink Corp. | MKJ | Class III | |
| K010140 | Hrh-127 Head Array Coil | Mri Devices Corp. | MOS | Class II | |
| K010025 | Electricator Model 26000 | Dermatologic Lab & Supply, Inc. | GEI | Class II | |
| K010007 | Adapt Laparoscopic Port & Adapt Reducer Cap | Taut, Inc. | GCJ | Class II | |
| K003914 | Medtronic Ps Medical Neuropen Endoscope and Optical Accessories | Medtronic PS Medical | GWG | Class II | |
| K003885 | Visulas Yag II | Carl Zeiss, Inc. | GEX | Class II | |
| K003807 | Cystoscopes | Global Endoscopy, Inc. | FAJ | Class II | |
| K003806 | Ureteroscopes | Global Endoscopy, Inc. | FGB | Class II | |
| K003703 | Taut-Insufflation Needle | Taut, Inc. | HIF | Class II | |
| K003672 | Medge Platforms Sonocubic 3D Ultrasound Software | Medge Platforms, Inc. | IYO | Class II | |
| K003646 | Suturegroove Weight Sizing Set | Iop, Inc. | MML | Class II | |
| K003640 | Miniendo III | Sybron Dental Specialties, Inc. | ELB | Class II | |
| K003629 | Mtp Resesurfacing Joint-Small/9301-01; Medium/9301-02; Large/9301-03 | Terray Corp. | KWD | Class II | |
| K003423 | St. Francis Operating Theatre Lamp, Models Olh01-125 and Lc-055 | St. Francis Medical Equipment Co., Ltd. | FTD | Class II |