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 |
|---|---|---|---|---|---|
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | LLZ | Class II | |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd | IZL | Class II | |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | |
| K253169 | Duet™ Spinal Fixation System | Box Spine, LLC | NKB | Class II | |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health Pte. Ltd. | FMF | Class II | |
| K252795 | ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | Argon Medical Devices, Inc | KNW | Class II | |
| K251864 | Rubber Utility Catheter | C.R. Bard Inc | KOD | Class II | |
| K251661 | Mariana Minerva; Mariana Nimbus | ResMed Corp | MNS | Class II | |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. KG. | KLE | Class II | |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | FDT | Class II | |
| K251692 | Advanced Tissue Resection Device | Micro-Tech (Nanjing) Co., Ltd. | FDI | Class II | |
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | JOJ | Class II | |
| K254162 | KLS Martin Ixos System | KLS-Martin L.P. | HRS | Class II | |
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo Inc | OHS | Class II | |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | HRS | Class II | |
| K253653 | Xpert Hemorrhagic Fever | Cepheid | |||
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | FMK | Class II | |
| K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | BD | FQH | Class II | |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech Inc. | OLO | Class II | |
| K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster Inc | DQK | Class II | |
| K252672 | CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) | Casebioscience, Inc. | MQL | Class II | |
| K252619 | Qscheck Uisacr | Qstag, Inc. | JFY | Class II | |
| K252500 | CARA System | Cara Medical, Ltd. | OWB | Class II | |
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FAD | Class II | |
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical,Inc. | OBP | Class II | |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | MUJ | Class II | |
| K260218 | LacertaMatrix | Lacerta Life Sciences | KGN | Unclassified | |
| K260205 | AS Software Version Asera | As Software, LLC | LLZ | Class II | |
| K260163 | AuST CSP Introducer | Centerpoint Systems LLC | DYB | Class II | |
| K254188 | Meniscus Versaflex | GM dos Reis Industria e Comercio Ltda | GAT | Class II | |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | OLO | Class II | |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | EHD | Class II | |
| K253687 | Access anti-HBc Total | Siemens Healthcare Diagnostics Inc. | SEI | Class II | |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent Inc | PNZ | Class II | |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | FXX | Class II | |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | DWF | Class II | |
| K253002 | SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | QAI | Class II | |
| K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe | CMT Health Pte. Ltd. | QNQ | Class II | |
| K252733 | ATLAS™ Expandable Osteotomy Wedge System | Mirus, LLC | PLF | Class II | |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | OLO | Class II | |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | MUJ | Class II | |
| K251903 | Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation | NHN | Class II | |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Corp. | GCJ | Class II | |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | INI | Class II | |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., dba Stryker Orthopaedics | MBH | Class II | |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | NBC | Class II | |
| K252561 | Btl-754Ff | BTL Industries, Inc | GEX | Class II | |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | DZE | Class II | |
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | MEG | Class II |