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 |
|---|---|---|---|---|---|
| K261366 | Virtus | Somnomed Inc. | LRK | Class II | |
| K261213 | Medical Monitor (40HT513D) | LG Electronics.Inc | PGY | Class II | |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical | HRS | Class II | |
| K261204 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co.,Ltd | ONF | Class II | |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | ITI | Class II | |
| K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | SBH | Class II | |
| K260635 | HARBOR Occlusion Device | Nuvascular Inc. | KRD | Class II | |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health Pte. Ltd. | FMF | Class II | |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | QIH | Class II | |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | HGX | Class II | |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | PHX | Class II | |
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Medrad, Inc. | PQH | Class II | |
| K253437 | Spiro-VISTA | Spiro Robotics | BTR | Class II | |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corp | MWI | Class II | |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty. Ltd. | DQK | Class II | |
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | Voxneuro, Inc. | OLU | Class II | |
| K252996 | Universal 1417PI | Konica Minolta, Inc. | MQB | Class II | |
| K252987 | ADRx™ Admixture Device | Epic Medical Pte., Ltd. | LHI | Class II | |
| K252963 | Btl-899Tt | BTL Industries, Inc | IMJ | Class II | |
| K252937 | ThinkQA 3 | Dosisoft | IYE | Class II | |
| K252933 | Dyne Port | Dyne Medical Group Inc. | ODC | Class II | |
| K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | QOF | Class II | |
| K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics GmbH | PZI | Class II | |
| K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | NEW | Class II | |
| K261610 | Verge™ Microcatheter | Instylla, Inc. | KRA | Class II | |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | NUC | Class II | |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | LXB | Class II | |
| K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | LRK | Class II | |
| K261209 | Ion-L | Surgentec LLC | MRW | Unclassified | |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | EIH | Class II | |
| K260849 | Icon 35; Icon 45; Icon 60; Icon 30Faf | Rehasense USA Inc | IOR | Class I | |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | GCJ | Class II | |
| K260653 | Dexter L6 System | Distalmotion SA | SDD | Class II | |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | QIH | Class II | |
| K260174 | Probeat-Cr | Hitachi High-Tech Corp. | LHN | Class II | |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | NHA | Class II | |
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System | Synthes (USA) Products LLC | KTT | Class II | |
| K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | QME | Class II | |
| K253607 | UNEEG EpiSight System | Uneeg Medical A/S | SEM | Class II | |
| K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | LBH | Class II | |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Medical | MMI | Class II | |
| K251326 | Respiration Rate algorithm | Edwards Lifesciences LLC | BZQ | Class II | |
| K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | OAS | Class II | |
| K250129 | AViTA Breast Pump | Avita Corporation | HGX | Class II | |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | DQK | Class II | |
| K261174 | RxSight® Insertion Device | RxSight Inc. | MSS | Class I | |
| K261016 | MSS - Humeral reverse liners extension | Medacta International SA | PHX | Class II | |
| K260855 | Profoject™ Safety Pen Needles | CMT Health Pte. Ltd. | FMI | Class II | |
| K260810 | Anteralign LS coverplate | Tyber Medical | OVD | Class II | |
| K260614 | Tinnitus Therapy | Sivantos Pte Ltd | KLW | Class II |