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 |
|---|---|---|---|---|---|
| K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid | Eco Medi Glove Sdn Bhd | LZA | Class I | |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | GCA | Class II | |
| K232628 | VADER® Pedicle System | Icotec AG | NKB | Class II | |
| K232084 | Stellaris Elite vision enhancement system | Bausch & Lomb Incorporated | HQC | Class II | |
| K231822 | GOLFF Sterile Anti-Fog Solution | Batrik Medical Manufacturing Inc. | OCT | Class II | |
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology Inc. | PCC | Class II | |
| K230693 | BIS™ Advance Monitoring System | Medtronic, Inc. | OLW | Class II | |
| K240213 | Iconix Knotless Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K240212 | COGNiTiON™ Staple System | Ortho Solutions Inc | JDR | Class II | |
| K240201 | PathLoc SI Joint Fusion System | L&K Biomed Co.,Ltd. | OUR | Class II | |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic, Inc. | DTR | Class II | |
| K240011 | Lymphedema Compression | JKH Health Co., Ltd. | JOW | Class II | |
| K233995 | Ivotion Base Print | Ivoclar Vivadent, Inc. | EBI | Class II | |
| K233784 | ENSO (Model 2) | Hinge Health Inc. | NUH | Class II | |
| K233754 | AIO Breathe | Aiomega, LLC | LQZ | Class II | |
| K233722 | RADspeed Pro | Shimadzu Corp. | KPR | Class II | |
| K233709 | Exceed Unlimited | Mt. Derm GmbH | QAI | Class II | |
| K233590 | Overjet Charting Assist | Overjet | QIH | Class II | |
| K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | Shenzhen Konmed Technology Co., Ltd | KPI | Class II | |
| K232800 | Navigation Tracking Instruments | SI-Bone, Inc. | OLO | Class II | |
| K232536 | Soldier Microcatheter | Embolx Inc. | DQO | Class II | |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. | DJG | Class II | |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | GENOSS Co., Ltd. | EIH | Class II | |
| K232075 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia, Inc. | DFH | Class II | |
| K230423 | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co.,Ltd. | BZH | Class II | |
| DEN230025 | MIRA Surgical System | Virtual Incision Corporation | SAB | Class II | |
| K240313 | Oligio X | WONTECH Co., Ltd. | GEI | Class II | |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | Corcym Inc. | DWF | Class II | |
| K240174 | 1688 4K Camera System with Advanced Imaging Modality | Stryker Corp. | GCJ | Class II | |
| K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Merz North America, Inc. | OHV | Class II | |
| K233775 | Vivatmo pro | Bosch Healthcare Solutions GmbH | MXA | Class II | |
| K233749 | Revolution Ascend Sliding | GE Hangwei Medical Systems, Co. Ltd | JAK | Class II | |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | Alphatec Spine, Inc. | KWQ | Class II | |
| K233544 | Mesheet | Dentis Co.,Ltd | NXC | Class II | |
| K232831 | Quiver Aspiration Pump | Anoxia Medical, Inc. | BTA | Class II | |
| K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | Zhejiang Horizon Medical Technology Co., Ltd. | MQE | Class II | |
| K232074 | Serafin® | Tns Co., Ltd. | NXC | Class II | |
| K231876 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | HIR | Class II | |
| K223826 | NanoDrop Lancet | Drawbridge Health, Inc. | FMK | Class II | |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | ERGO FLEX Technologies LLC | ITH | Class II | |
| K240194 | ProCinch, QuadCinch | Riverpoint Medical, LLC | MBI | Class II | |
| K233439 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co.,Ltd. | IYN | Class II | |
| K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) | Visionary Optics, LLC | HQD | Class II | |
| K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty., Ltd. | DWJ | Class II | |
| K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | PHX | Class II |