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 |
|---|---|---|---|---|---|
| K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co.,Ltd | OLP | Class II | |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical Ltd | GEI | Class II | |
| K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies, Inc | HWC | Class II | |
| K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. | DXN | Class II | |
| K241593 | BoneMetrics (US) | Gleamer SAS | QIH | Class II | |
| K241488 | TrainFES Advance | Trainfes | IPF | Class II | |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | ClaroNav Inc. | HAW | Class II | |
| K250068 | Venclose digiRF Generator (VCRFG1) | Venclose, Inc. | GEI | Class II | |
| K243333 | rTOP | Roclub GmbH | LLZ | Class II | |
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | BTA | Class II | |
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | LPL | Class II | |
| K250035 | Contour ProtégéAI+ | MIM Software Inc | QKB | Class II | |
| K243908 | Tiger 2 System | Zavation Medical Products, LLC | NKB | Class II | |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | Shenzhen Ulike Smart Electronics Co.,Ltd | NFO | Class II | |
| K243268 | TipTraQ (TTQ001) | Pranaq Pte. Ltd. | MNR | Class II | |
| K243182 | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | Momentis Surgical Ltd. | QNM | Class II | |
| K243146 | iCare APP | iHealth Labs, Inc. | MWI | Class II | |
| K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | Guangdong Xinyu Electronic and Technology Co., Ltd | DXN | Class II | |
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | Guangzhou Hehong Biotech Co., Ltd. | MQK | Class II | |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | Alphatec Spine, Inc. | MAX | Class II | |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K240402 | Cito CBC System | Cytochip, Inc. | GKZ | Class II | |
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | Dornier Medtech America, Inc. | FED | Class II | |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex GmbH | JDR | Class II | |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | Zhejiang Decans Medical Devices Co.,Ltd. | MBI | Class II | |
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | Halyard Health | IRP | Class II | |
| K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | Basic Medical Technology Inc. | LZA | Class I | |
| K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.p.A. | SCR | Class II | |
| K242982 | Mobility Scooter (MS160A) | Suzhou Master Machinery Manufacturing Co.,Ltd. | INI | Class II | |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | DQO | Class II | |
| K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics Ltd. | HWC | Class II | |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. | LCX | Class II | |
| K241694 | ZeTTA PACS | Tae Young Soft Co., Ltd. | LLZ | Class II | |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount ApS | MQK | Class II | |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, | C.R. Bard Inc | LDF | Class II | |
| K241193 | AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) | Marzzan Lucas Jorge | JFB | Class II | |
| K243726 | Osprey Suture Anchor | Responsive Arthroscopy | MBI | Class II | |
| K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed, S.L. | MBI | Class II | |
| K243442 | iBOT® PMD | Mobius Mobility LLC | IMK | Class II | |
| K243410 | simpli-COLLECT STI Test | Abbott Molecular, Inc. | QYA | Class II | |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co.,Ltd | NBW | Class II | |
| K243025 | Ureteral Access Sheath | Seplou (Zhuhai) Co.,Ltd. | FED | Class II | |
| K242757 | Rotarex Atherectomy System | Bard Peripheral Vascular Inc | MCW | Class II | |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic, S.A. de C.V. | BTT | Class II | |
| K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | DXN | Class II | |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International SA | KWS | Class II | |
| K241270 | Btl-754 | BTL Industries, Inc | GEX | Class II | |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | |
| K243740 | Versalock Upper Limb Plating System | GM dos Reis Industria e Comercio Ltda | HRS | Class II |