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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K220742 | NxtGen Infant Transport Incubator | International Biomedical, Ltd. | FPL | Class II | |
| K220631 | NomadAir PMU810 | Neurotronics, LLC | GWL | Class II | |
| K220622 | Hailie Sensor NF0106 | Adherium (Nz), Ltd. | CAF | Class II | |
| K220619 | Vivid S60N, Vivid S70N | GE Healthcare | IYN | Class II | |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Neuronetics Inc. | OBP | Class II | |
| K213997 | Kontact Dental Implant System | Biotech Dental SAS | DZE | Class II | |
| K213872 | ComPAS2 | Morgan Scientific, Inc. | BZG | Class II | |
| K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. dba Tatum Surgical | DZE | Class II | |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | DRG | Class II | |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) | Abbott Molecular, Inc. | QLX | Class II | |
| K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | JXI | Class II | |
| K221666 | Normatec Go | Normatec Industries, LP | IRP | Class II | |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | Church & Dwight Co., Inc. | HIS | Class II | |
| K221429 | KDF Zirconia Disc | DENKEN-HIGHDENTAL Co., Ltd. | EIH | Class II | |
| K221203 | AHI System | Fifth Eye, Inc. | QNV | Class II | |
| K221097 | SmileSeries | Ordont Orthodontic Laboratories, Inc. | NXC | Class II | |
| K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | OLO | Class II | |
| K220560 | Dermatac Drape | 3M | OMP | Class II | |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | Remex Medical Corp. | OLO | Class II | |
| K220258 | 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) | Avia Vascular | JKA | Class II | |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle | Anhui Tiankang Medical Technology Co., Ltd. | FMF | Class II | |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems | Medos International SARL | HCG | Class II | |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | LYY | Class I | |
| K213961 | TruAbutment DS, TruBase | TruAbutment Inc. | NHA | Class II | |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | Diasorin Inc. | QPS | Class II | |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | Gunze Limited | KGN | Unclassified | |
| K212073 | Alma Diode Tabletop Laser | Alma Lasers Ltd. | GEX | Class II | |
| K203013 | Agnes | Agnes Medical Co.,Ltd | GEI | Class II | |
| K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K221434 | 17Hq701g-B | LG Electronics.Inc | MQB | Class II | |
| K221407 | truSculpt iD | Cutera Inc | GEI | Class II | |
| K210354 | SNUCONE Bone Level Implant System | Snucone Co., Ltd. | DZE | Class II | |
| K221454 | Disposable Medical Nitrile Examination Gloves - Non Sterile | Guangzhou Kangling Biotechnology Co., Ltd. | LZA | Class I | |
| K221108 | Nitrile Medical Examination Gloves | Anhui Fulewei Electronic Technology Co.,Ltd | LZA | Class I | |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Stryker Corp. | PGW | Class II | |
| K221083 | Smartlux Mini | medmix Co.,Ltd | GEX | Class II | |
| K220814 | NAEOTOM Alpha, Scan&GO Software | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K220415 | Protrieve Sheath | Inari Medical, Inc. | QEW | Class II | |
| K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin | bioMerieux, Inc. | LON | Class II | |
| K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K213574 | Nitrile Vinyl Blend Powder Free Examination Gloves (Black) | Grand Work Plastic Products Co., Ltd. | LZA | Class I | |
| K213143 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | |
| K203279 | Veuron-Brain-mN1 | Heuron Co., Ltd. | LNH | Class II | |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | Apollo Endosurgery, Inc. | QTD | Class II | |
| K221846 | Artix Ballon Guiding Sheath | Inari Medical, Inc. | DQY | Class II | |
| K221364 | Mitek TIGHT-N Anchor | Medos International SARL | MBI | Class II | |
| K220538 | DolorClast Radial | E.M.S. - Electro Medical Systems SA | ISA | Class I | |
| K220480 | Revogene | Meridian Bioscience Inc | OOI | Class II | |
| K220095 | ANNE Sleep | Sibel, Inc. | MNR | Class II | |
| K213405 | MINE ALNU (Model: Mine 2.1) | Hdt Co., Ltd. | IZL | Class II |