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 |
|---|---|---|---|---|---|
| K202079 | Physiq | El.en. Electronic Engineering SpA | IPF | Class II | |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | Abbott Medical | DQK | Class II | |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical Inc | BTR | Class II | |
| K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster Inc | DQK | Class II | |
| K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd | GYB | Class II | |
| K193377 | TopLock Anchor System | Fusion Orthopedics, LLC | MBI | Class II | |
| K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corporation | KPO | Class II | |
| K192406 | AveCure BT Microwave Ablation System | MedWaves, Inc | NEY | Class II | |
| K192285 | CPR Face Shield | FIRSTAR HEALTHCARE Company Limited (Guangzhou) | CBP | Class II | |
| K192177 | SysMed S/T | Sysmed (China) Co., Ltd | BZD | Class II | |
| DEN200029 | Parallel | Mahana Therapeutics, Inc. | QMY | Class II | |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | Lsi Solutions Inc. | GAS | Class II | |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | Lsi Solutions Inc. | GAS | Class II | |
| K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | PENTAX of America, Inc. | GEH | Class II | |
| K202972 | Anterior Cervical Plate System | Nutech Spine and Biologics | KWQ | Class II | |
| K202959 | PolyLock Plating System | Fusion Orthopedics, LLC | HRS | Class II | |
| K202943 | OptoMonitor 3 | Opsens Inc. | DXO | Class II | |
| K202682 | Promisemed Triple Safety Pen Needle | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K202515 | NUVO Implant System – NUVO Instrument Kit Cases | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K201904 | Monet Curing Laser | Cao Group, Inc. | QNF | Class II | |
| K201742 | eKuore One Wireless Electronic Interface for stethoscope | Chip Ideas Electronics S.L. | DQD | Class II | |
| K201622 | Medical surgical mask | Guangdong Kingfa Sci.&tech.co.,Ltd. | FXX | Class II | |
| K200931 | RF Surgical Generator | Fulwell LLC | GEI | Class II | |
| K200798 | G-Cem One | GC America Inc. | EMA | Class II | |
| K193158 | ACENT™ Central Venous Catheter | Global Medikit Limited | FOZ | Class II | |
| DEN190047 | CADScor System | Acarix AS | QMW | Class II | |
| K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | |
| K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | MXC | Class II | |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | Heraeus Medical GmbH | LOD | Class II | |
| K201991 | Medical surgical mask | Shenzhen Everwin Precision Technology Co., Ltd. | FXX | Class II | |
| K201484 | Somnos Anti-Snoring Mouth Guard | Koncept Innovators, LLC | LRK | Class II | |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | M/s. Meril Endo Surgery Private Limited. | FZP | Class II | |
| K193621 | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | Dongguan e-Test Technology Co.,Ltd | FLL | Class II | |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Molnlycke Health Care, US LLC | KGO | Class I | |
| K203179 | Fortress Introducer Sheath System | Contract Medical International GmbH | DYB | Class II | |
| K203169 | Revolution Ascend | GE Healthcare Japan Corporation | JAK | Class II | |
| K203156 | DTX Studio Clinic | Nobel Biocare AB | LLZ | Class II | |
| K203100 | Arthrex Eclipse Titanium Humeral Head | Arthrex GmbH | PKC | Class II | |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft | New Deantronics Taiwan Ltd. | GEI | Class II | |
| K202805 | Optimized Positioning System (OPS) Insight | Corin USA | LLZ | Class II | |
| K202764 | Ortho Solutions Plating System | Ortho Solutions Inc | HRS | Class II | |
| K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring | Prosomnus Sleep Technologies | LRK | Class II | |
| K202413 | LC ResinCal PC | S&C Polymer Silicon- und Composite Spezialitaten GmbH | EJK | Class II | |
| K202382 | FilmArray Global Fever Panel External Control Kit | BioFire Defense, LLC | PMN | Class II | |
| K202139 | Medical surgical mask | Guangdong Kingfa Sci.&tech.co.,Ltd. | FXX | Class II | |
| K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC. | OWQ | Class II | |
| K202035 | Vscan Air | GE Healthcare | ITX | Class II | |
| K202000 | Silatrix Oral Gel | Sa3, LLC | OLR | Unclassified | |
| K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc | DTR | Class II |