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 |
|---|---|---|---|---|---|
| K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | PEM | Class II | |
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | GEI | Class II | |
| K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | MBI | Class II | |
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | |
| K261729 | EnSite™ X EP System | Abbott Medical | DQK | Class II | |
| K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | |
| K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | DZE | Class II | |
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | MBH | Class II | |
| K261266 | MOWANA™ Auto Duo | Pentamaster Mediq Sdn Bhd | FMI | Class II | |
| K260677 | Vessel Closure Device (VCD177213P) | Vcd Medical S.R.L. | FZP | Class II | |
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | LZO | Class II | |
| K254260 | The VEGA Cervical Screw System | GS Medical Co., Ltd. | NKG | Class II | |
| K254203 | Wearable Breast Pump (Model S36) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | GEI | Class II | |
| K252995 | Durashield Device Kit | SurGenTec, LLC | GZT | Class II | |
| K262877 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | |
| K262559 | Mouth Guard | ChangSha ChuangDuoLe E-Commerce Co., Ltd. | OBR | Unclassified | |
| K262054 | Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. | ITI | Class II | |
| K261919 | Multifunctional wheelchair (YJ-059) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | |
| K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | MSB | Class II | |
| K261896 | iOS CamAPS FX | CamDiab | QJI | Class II | |
| K261888 | ClearClub Impression Material | ClearClub | SHI | Class II | |
| K261865 | AerFrame™ Alignment Laser Box (LBV2) | Stabilix, LLC | IYE | Class II | |
| K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | PNO | Class II | |
| K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | LNH | Class II | |
| K261712 | Ceribell EEG Analysis Software | Ceribell, Inc. | OLT | Class II | |
| K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH | Class II | |
| K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. | SAH | Class II | |
| K261400 | Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large | Ambu A/S | FDS | Class II | |
| K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | NFO | Class II | |
| K261283 | APERTO Lucent MRI System | Fujifilm Corporation | LNH | Class II | |
| K260906 | a2z-Abdo-Triage | A2z Radiology Ai, Inc. | QAS | Class II | |
| K260309 | Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | EOQ | Class II | |
| K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | BZK | Class II | |
| K260220 | Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. | QJP | Class II | |
| K254212 | NC PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LIT | Class II | |
| K254181 | Aristotle 65 Macrowire | Scientia Vascular | MOF | Class II | |
| K254152 | Dia-X Sil Light Body | DiaDent Group International | ELW | Class II | |
| K254142 | Dia-X Sil Heavy Body | DiaDent Group International | ELW | Class II | |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | HRS | Class II | |
| K262057 | GMK Extension | Medacta International SA | JWH | Class II | |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | LLZ | Class II | |
| K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | QIH | Class II | |
| K261447 | CVAC® Aspiration System | Calyxo, Inc. | FGB | Class II | |
| K261070 | LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | GEI | Class II | |
| K260446 | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | HAE | Class II | |
| K260145 | YJ-K1K2 Wheelchair (YJ-013F) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | |
| K260144 | Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | |
| K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | |
| K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) | Karl Storz SE & CO. KG | EOB | Class II |