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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K173713 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K173605 | iQMR | Medic Vision - Imaging Solutions, Ltd. | LLZ | Class II | |
| K173500 | Nmf004a | GC America Inc. | EBF | Class II | |
| K173440 | Carriere SLX 3D Clear | Ortho Organizers Inc | NJM | Class II | |
| K173323 | AnastoClip GC Closure System | LeMaitre Vascular Inc. | FZP | Class II | |
| K173249 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | DxNow Inc. | MQK | Class II | |
| K172892 | Neuro Assessment System NAS-1000 | Headsense Medical, Inc. | QBE | Class II | |
| K172115 | Navigated Instrument System | Orthofix SRL | OLO | Class II | |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws | Meril Healthcare Pvt. Ltd. | HRS | Class II | |
| K171150 | Aw-100 | Micron Corp. | ELC | Class II | |
| K180350 | Dornier Medilas H Solvo 35 Laser | Dornier Medtech America, Inc. | GEX | Class II | |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap Inc | GAW | Class II | |
| K180196 | On Call Express Mobile Blood Glucose Monitoring System | Acon Laboratories, Inc. | NBW | Class II | |
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | PEK | Class II | |
| K173114 | primeMidline Catheters | PFM Medical GmbH | PND | Class II | |
| K172818 | Lmt-3000 | Lameditech Co., Ltd. | GEX | Class II | |
| K172810 | Port-X IV | Genoray Co., Ltd. | EHD | Class II | |
| K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FDI | Class II | |
| K171939 | ALVUE Balloon Dilation System | Globus Medical, Inc. | GCJ | Class II | |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | KOD | Class II | |
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) | Medrad, Inc. | NUH | Class II | |
| K173494 | OrthoSteady G Bone Cement | G21, S.r.l. | LOD | Class II | |
| K173356 | Ingenia Elition S and Ingenia Elition X R5.4 | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC. | OWQ | Class II | |
| K172381 | Digitimer DS7AP Constant Current Stimulator | Digitimer Ltd. | IPF | Class II | |
| K172267 | IRENE Thoracolumbar Fixation System | Tianjin Zhengtian Medical Instrument Co., Ltd. | NKB | Class II | |
| K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | KPO | Class II | |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23AndMe, Inc. | QAZ | Class II | |
| K180334 | LEGION Knee System | Smith & Nephew, Inc. | JWH | Class II | |
| K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Central Medicare Sdn Bhd | LZC | Class I | |
| K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | FPA | Class II | |
| K173741 | Reprocessed ArthoCare Ablation Wand | ReNovo, Inc. | NUJ | Class II | |
| K173723 | EMPOWR Universal Tibial Baseplate | Encore Medical, LP | JWH | Class II | |
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device | Amedica Corp. | ODP | Class II | |
| K172872 | DePuy Synthes Femoral Neck System | DePuy Synthes | KTT | Class II | |
| K172663 | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | FDX | Class II | |
| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | Medscience Science Research Group, Inc. | SCL | Class II | |
| K171715 | HammerTube System | Paragon 28 | HTY | Class II | |
| K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | IYO | Class II | |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) | CooperSurgical, Inc. | MQL | Class II | |
| K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | Phadia AB | OYL | Class II | |
| K173624 | ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) | CooperSurgical, Inc. | MQL | Class II | |
| K173544 | Phoenix Wound Matrix | Nanofiber Solutions LLC | QSZ | Unclassified | |
| K173447 | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit | KCI USA, Inc. | OMP | Class II | |
| K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | JOJ | Class II | |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | LENSAR, Inc | OOE | Class II | |
| K173312 | ProBx Software | Harmonus, Inc. | LLZ | Class II | |
| K173281 | LigaSure Exact Dissector, Nano-coated | Medtronic, Inc. | GEI | Class II |