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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K002735 | Ascent Xxl Open Box Femoral Component | Zimmer GmbH | JWH | Class II | |
| K002678 | Ascent Knee System | Zimmer GmbH | JWH | Class II | |
| K002413 | Ultrasorb Suture Anchor | Li Medical Technologies, Inc. | MAI | Class II | |
| K002073 | Pain Care 3000 | Breg, Inc. | MEB | Class II | |
| K001918 | Ksea Percutaneous Foraminoscopy Set | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K001901 | Poly per-Q-Cath Picc Catheter,model 3236100 and Poly per-Q-Cath Midline Catheter, Model 3134135 | C.R. Bard Inc | LJS | Class II | |
| K001882 | Baby Dopplex 4002-Twins, Model Bd4002 | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K001768 | Occu-Flo Punctum Plugs | U.S. Iol, Inc. | LZU | Unclassified | |
| K001366 | Prostec 125I Branchytherapy Snapseed | Prostec, LLC | KXK | Class II | |
| K001093 | Candela Sptl-1B Pulsed Dye Laser | Candela Corporation | GEX | Class II | |
| K000727 | Bufflight Clt Surgical Laser System | Y-Beam Technologies, Inc. | GEX | Class II | |
| K994420 | Powder Free Latex Examination Patient Gloves | Purna Bina Sdn Bhd | LYY | Class I | |
| K993282 | Ipi Humidifier Chamber | I.P.I. Medical Products | BTT | Class II | |
| K002750 | Hl168t | Health & Life Corporation | DXN | Class II | |
| K002679 | 6060 Multi-Therapy Pump, Model 2M9832; 6060 Epidural Pump, Model 2L9351 | Baxter Healthcare Corporation | FRN | Class II | |
| K002540 | Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems | Bionostics, Inc. | JJX | Class I | |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium, | Cook Ob/Gyn | MQL | Class II | |
| K002366 | Quest Mps Back-Up Sysyem | Quest Medical, Inc | DWF | Class II | |
| K002329 | Pelvx Gellhorn Vaginal Pessary 603-608 | Deschutes Medical Products, Inc. | HHW | Class II | |
| K002322 | Modification to Panavia F | Kuraray America, Inc. | EMA | Class II | |
| K002255 | Laryngo-Tracheal Mucosal Atomization Device (Madgic) | Wolfe Tory Medical, Inc. | CCT | Class II | |
| K001869 | Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle | Medicotest, Inc. | IKT | Class II | |
| K001599 | Acti-Flex IV Administration Set | R-Group Intl. | FPA | Class II | |
| K001175 | Seragard Vascular Access Patch | Platinum Services, Inc. | FMI | Class II | |
| K000678 | Raebbitt/evolution Powered Wheelchair | Otto Bock Orthopedic Industry, Inc. | ITI | Class II | |
| K980937 | Nicore Model Esp -1 | Nicore Equipment & Leasing, Inc. | DRN | Class II | |
| K002694 | Urea-L3k Assay, Catalogue Number 283-17/30 | Sekisui Diagnostics P.E.I. Inc. | CDQ | Class II | |
| K002685 | Cordless Compact Mobile X-Ray System | Medison Radiology Systems, Inc. | IZL | Class II | |
| K002553 | Ds Ds I-Series | Smv America | KPS | Class II | |
| K002371 | K-Centrum Anterior Spinal Fixation System | Spineology, Inc. | KWQ | Class II | |
| K001842 | Adult/pediatric Cerebral Oximeter, Model Invos 5100 | Somanetics Corp. | DQA | Class II | |
| K001486 | Genx Coda Air Purification System | <Genx> Intl., Inc. | MQG | Class II | |
| K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2Rg051, 2Rg101, 2Rg151, 2Rg201, 2Rg301, 2Rg050, 2Rg100, 2Rg150, | Interpore Cross Intl. | MQV | Class II | |
| K993933 | 14 Fr Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+ard Blue Catheter for High Volume Infusions, Pro | Arrow Intl., Inc. | MPB | Class II | |
| K002734 | Aspect Medical Sytems EEG Enhanced Bis Sensor 186-0106 | Aspect Medical Systems, Inc. | GXY | Class II | |
| K002570 | Bio-Logic Ceegraph Netlink | Bio-Logic Systems Corp. | GWQ | Class II | |
| K002320 | Accolade C Femoral Component | Howmedica Osteonics Corp | LZO | Class II | |
| K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 Series | Haemoscope Corp. | JPA | Class II | |
| K994137 | Atrisorb-D Freeflow Bioabsorbable Guided Tissue Regeneration (Gtr) Barrier with 4% Doxycycline | Atrix Laboratories, Inc. | LYC | Class II | |
| K993773 | Humid-Heat | Hudson Rcj AB | BTT | Class II | |
| K992476 | Pilling Weck Surgical Heart Stabilizer Removable Pads | Pilling Weck Surgical | MWS | Class I | |
| K002701 | Powder Free Latex Examination Gloves with Water Extractable Protein Labeling Claim. (50 Micrograms or Less) | Alliance Rubber Products Sdn. Bhd. | LYY | Class I | |
| K002682 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K002647 | Marietta Contact Lens Service, Color Enhanced Tinted Soft Contact Lens | Marietta Contact Lens Service | LPL | Class II | |
| K002625 | Methafilcon a | CooperVision, Inc. | LPL | Class II | |
| K002591 | Cobe Smarxt Vvr 4000 Filtered Hardshell Venous Reservoir | LivaNova USA, Inc. | DTP | Class II | |
| K002544 | Medilog Excel 2 - Holter Management System | Oxford Instruments, PLC. | DQK | Class II | |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit | Cook Ob/Gyn | MQL | Class II | |
| K002293 | 3D Motor-Driven Coarse Manipulator Mm-188Ne | Narishige Co., Ltd. | MQJ | Class II | |
| K002291 | Motor-Drive Manipulator Mm-89 | Narishige Co., Ltd. | MQJ | Class II |