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 |
|---|---|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc | GXQ | Class II | |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | DXH | Class II | |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical | LJS | Class II | |
| K252330 | DeepRESP | Nox Medical Ehf | OLZ | Class II | |
| K252086 | DTX Studio Assist | Nobel Biocare c/o Medicim NV | MYN | Class II | |
| K251566 | TS-RF Generator (STS10) | Starmed Co.,Ltd | GEI | Class II | |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand) Ltd. | LZA | Class I | |
| K250588 | Access Rubella IgG | Siemens Healthcare Diagnostics Inc. | LFX | Class II | |
| K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate Inc | LSR | Class II | |
| K252618 | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co., Ltd. | OHT | Class II | |
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited | FRF | Class II | |
| K251821 | ARC-EX System | ONWARD Medical Inc. | SDO | Class II | |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | KCT | Class II | |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | CAF | Class II | |
| K251538 | Status™ COVID-19/Flu A&B | Princeton BioMeditech Corp. | SCA | Class II | |
| K251078 | AutoDensity | EOS imaging | QIH | Class II | |
| K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | HRS | Class II | |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | MYN | Class II | |
| K250501 | System Sophi | This AG | HQC | Class II | |
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | |
| DEN250015 | Neurolyser XR (NXR100) | Fusmobile, Inc | SGN | Class II | |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc | HRS | Class II | |
| K252592 | TELLTALE Electrosurgical Guidewire System | Telltale, LLC | SGO | Class II | |
| K252308 | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | OHS | Class II | |
| K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd | OAS | Class II | |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co.,Ltd | IRP | Class II | |
| K251314 | Rosa® Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K253290 | Xstat P15 | Revmedx Inc | PGZ | Class II | |
| K252959 | WRISTAR MultiAx Distal Radius Kit | Intrauma | HRS | Class II | |
| K252829 | Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. | ITI | Class II | |
| K252452 | PeekMed web | Peek Health, S.A. | QIH | Class II | |
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | NKG | Class II | |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical, LP | LPH | Class II | |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Olympus Medical Systems Corp. | OWN | Class II | |
| K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | Ethicon, Inc | NEW | Class II | |
| K243715 | Synthes Patient Specific Implants | Synthes GmbH | GXN | Class II | |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | KLS-Martin L.P. | GXN | Class II | |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | MUH | Class II | |
| K252560 | Atlas Spine HiRISE™ Expandable Cervical Corpectomy System | Atlas Spine, Inc. | PLR | Class II | |
| K252474 | Withings BeamO (SCT02) | Withings | DPS | Class II | |
| K252287 | Symani Surgical System | Medical Microinstruments, Inc. | SAQ | Class II | |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Boblingen GmbH | MHX | Class II | |
| K251006 | NeVasc Aspiration System | Vesalio | NRY | Class II | |
| K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe ApS | DQX | Class II | |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Co | EBF | Class II | |
| K253039 | Auto Kerato-Refracto Tonometer Trk-3 Omnia | Topcon Corp. | HKX | Class II | |
| K252564 | Medical Diode Laser Systems (VeinCure) | Baoding Te'anzhou Electronic Technology Co.,Ltd. | GEX | Class II |