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 |
|---|---|---|---|---|---|
| K073571 | Tricos T Resorbable Bone Substitute | Baxter Healthcare Corporation | LYC | Class II | |
| K073492 | Diachex+determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | |
| K073365 | Dental Digital X-Ray Imaging System | Vatech Co., Ltd. | MUH | Class II | |
| K072302 | Entellus Medical Rs-Series System | Entellus Medical, Inc. | LRC | Class I | |
| K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | IYN | Class II | |
| K080697 | Skin Clear Srvh Long-Pulsed Nd: Yag Laser | Global USA Distribution, LLC | GEX | Class II | |
| K080572 | Ldr Spine Roi-a Implant | Ldr Spine USA | MQP | Class II | |
| K080305 | Nexcomp and Meta Etchant | Meta Biomed Co., Ltd. | EBF | Class II | |
| K073465 | Us/gs Ultra Wide System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K073143 | Modified Vertiflex Spinal Screw System | Vertiflex, Inc. | MNI | Class II | |
| K072885 | Carina System, Model 8419350; Carina Basic Device, Model 5704110 | Draeger Medical AG & Co. KG | CBK | Class II | |
| K072414 | Cryostat | Lil Drug Store Products, Inc. | LKX | Unclassified | |
| K080827 | Handan N95 Particulate Respirators and Surgical Mask, Models Hy8510 and Hy9810 | Handan Hengyong Protective & Clean Products Co., L | MSH | Class II | |
| K080806 | Angiojet Ultra Spiroflex Vg Thrombectomy Set, Model 106608 | Possis Medical, Inc. | QEZ | Class II | |
| K080735 | Cryomini | Zimmer Elektromedizin GmbH | GEX | Class II | |
| K080681 | Kowa Genesis-D | Kowa Co., Ltd. | HKI | Class II | |
| K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | JAQ | Class II | |
| K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | EIA | Class I | |
| K080060 | Vivosonic Neuroscreen | Vivosonic Inc. | GWJ | Class II | |
| K080043 | Vizilite Eyewear | Zila, Inc. | NXV | Class II | |
| K073486 | Dentis Dental Implant System | Dentis Co.,Ltd | DZE | Class II | |
| K073458 | Bt-Tite One(bticv1), Bt-Tite Standard(btivsm), Bt-Tite Cv2(bticv2) | Btlock SRL | DZE | Class II | |
| K073364 | Expedium 4.5Mm Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K072583 | Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model(s) Chx30, Bsq-Chx 30 | MAQUET CARDIOPULMONARY GmbH | DTR | Class II | |
| K072444 | Wellgraft Pe I | Gwowei Technology Co., Ltd. | MQV | Class II | |
| K072170 | Wellgraft Pe II | Gwowei Technology Co., Ltd. | MQV | Class II | |
| K072032 | Igg Anti-Atherox Test Kit | Corgenix, Inc. | MSV | Class II | |
| K071483 | Tetrix Cream | Coria Laboratories, Ltd. | FRO | Unclassified | |
| K070217 | Interx 1000/Derma 200 Stimulator for Cosmetic Use | InterX Technologies | NFO | Class II | |
| K063437 | Accubind Neo-Tsh Microwell Elisa, Model 3425-300 | Monobind, Inc. | JLW | Class II | |
| K080789 | Blood Pressure Monitor, Models Bp-102, Bp-103, Bp-201 and Bp-202 | Sejoy Electronics & Instruments Co., Ltd. | DXN | Class II | |
| K080353 | Ltm-T Surgical Mesh | LifeCell Corp | FTL | Class II | |
| K080192 | Hypervisor VI Central Monitoring System (Including Tms) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MSX | Class II | |
| K080042 | Spirus Medical Surgical Instrument | Spirus Medical, LLC | KMJ | Class I | |
| K073534 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | Candela Corporation | GEX | Class II | |
| K073483 | Sapphire O/e Oral Examination System | Den-Mat Holdings, LLC | NXV | Class II | |
| K073132 | Model D Disc Force | North American Medical Corp (Nam) | ITH | Class II | |
| K080820 | Tem 3002G- Hn Dual Tune Head Coil | Mr Instruments, Inc. | MOS | Class II | |
| K080784 | Wbr Xpress.cardiac, Wbr Xpress.bone; Wbr Xact.cardiac, Wbr Xact.bone | Ultraspect, Ltd. | KPS | Class II | |
| K080753 | Aesculap Endoscopic Clip Sytem | Aesculap Inc | FZP | Class II | |
| K080715 | Erbe Vio Esu, Model Vio 200 S | Erbe USA Inc | GEI | Class II | |
| K080622 | Entity Nasoview LED Nasopharyngoscope, Model 006105 | Optim LLC | EOB | Class II | |
| K080593 | Fora Comfort 4 in 1 Ear Thermometer, Model Td-1116 | Taidoc Technology Corporation | FLL | Class II | |
| K080557 | Barrx Models Halo360 and Halo360+ Coagulation Catheters | Barrx Medical, Incorporated | GEI | Class II | |
| K080444 | Conmed Linvatec Osprey Drill System | Conmed Linvatec | HBC | Class II | |
| K080376 | Oncobionic System | Oncobionic Incorporated | OAB | Class II | |
| K080191 | Eagle Plus Micro Anterior Cervical Plate System | DePuy Spine, Inc. | KWQ | Class II | |
| K073494 | Clever Chek Blood Glucose Monitoring System, Models Td-4209, -4222, -4225 and -4226 and Achtung Blood Glucose Monitoring | Taidoc Technology Corporation | NBW | Class II | |
| K073468 | Mimics | Materialise N.V. | LLZ | Class II | |
| K073445 | Clever Td-3026 Digital Wrist Blood Pressure Monitor, Model Td-3026 | Taidoc Technology Corporation | DXN | Class II |