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 |
|---|---|---|---|---|---|
| K000788 | Apex Modular Hip Stem | VQ Orthocare | LPH | Class II | |
| K000653 | Aeronox Universal, Model P/n 360000, Aeronox Bedside, Model P/n 360001, Aeronox Transport Transport, Model P/n 360002 | Pulmonox Medical, Inc. | MRN | Class II | |
| K000593 | Sonic, Model So-100 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | |
| K000568 | Hdl Cholesterol Plus | Roche Diagnostics GmbH | LBT | Class I | |
| K000084 | Enraf-Nonius Sonopuls 190 System | Henley Healthcare, Inc. | IMI | Class II | |
| K994155 | Excelsior 1018 Microcatheter | Boston Scientific Corporation | KRA | Class II | |
| K994109 | Detrusan 500 | Innovamed USA, Inc. | KPI | Class II | |
| K993442 | Vygon Lifecath-Picc (Pur) Catheters (Single and Double Lumen 3Fr, 4Fr, 4.5Fr, and 5Fr) | Vygon Corp. | LJS | Class II | |
| K993052 | Vygon 2 Fr Epicutaneo Pur-Catheter | Vygon Corp. | LJS | Class II | |
| K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Medtronic, Inc. | DQX | Class II | |
| K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | HAW | Class II | |
| K001878 | Water Purifier | Waterclave, LLC | EIA | Class I | |
| K001641 | Tampons | Rostam, Ltd. | HEB | Class II | |
| K001553 | Breas Pv 100 CPAP System | Vital Signs, Inc. | BZD | Class II | |
| K993140 | Water for Tissue Culture, Models 1500 | Conception Technologies | MTW | Class II | |
| K990100 | Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle | Te ME NA S.A.R.L. | GXZ | Class II | |
| K002009 | Hp M2376a Device Link System, Model M2376a | Agilent Technologies, Inc. | MWI | Class II | |
| K001928 | Sigma | Instrumentarium Imaging, Inc. | MUH | Class II | |
| K001825 | Standard Imaging Hdr 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion Chamber | Standard Imaging Inc. | JAQ | Class II | |
| K001736 | Galeo Hydro and Galeo Hydro J-Tip | BIOTRONIK AG | DQX | Class II | |
| K001662 | Chase Cardiovascular Patch | Chase Medical, Inc. | DXZ | Class II | |
| K001590 | Dnd 101 | Urogyn, Ltd. | KNA | Class II | |
| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26 | Abbott Medical | HHK | Class II | |
| K001409 | Gamow Bag, Hyper Oxy, Hyper Oxy P/t, Pressure-Cizer | Hyperbaric Technologies, Inc. | CBF | Class II | |
| K001077 | Lubrigel Personal Lubricant | Sheffield Laboratories, Div. of Faria Limited, LLC | NUC | Class II | |
| K993524 | Advantis Asc Infusion Pump and Administration Sets | CareFusion 303, Inc | FRN | Class II | |
| K992905 | Codman Craniosorb Absorbable Fixation System | Cerenovus, Inc. | JEY | Class II | |
| K990517 | Explorer Cvs Transcranial Doppler | Diagnostic Medical Systems | IYN | Class II | |
| K002185 | Sonoace Sa 9900 Diagnostic Ultrasound System | Medison America, Inc. | IYN | Class II | |
| K002085 | Ultrasound Scanner, Type 1101 | B & K Medical A/S | IYO | Class II | |
| K001496 | A.v. Fistula Needle | Exelint International Co. | FIE | Class II | |
| K001467 | Da Vinchi Emg/ep Isa1004ep | Airsep Corp. | GWE | Class II | |
| K001410 | Phoresor Model Pm2000 | Iomed, Inc. | KTB | Class II | |
| K001400 | Elegra Millennium Enhanced Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K001182 | Microlife Wrist Watch Blood Pressure Monitor, Model Bp-3Bu1 | Microlife Corp. | DXN | Class II | |
| K000737 | Coaxial Dilator Set | Xentek Medical, Inc. | DRE | Class II | |
| K000204 | Win-1 Tango | Duracare Medical Equipment, L.C. | ITI | Class II | |
| K002323 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | FBK | Class II | |
| K002176 | Non-Sterile Powder Free Pineapple Scented Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms Le | Sgmp Co., Ltd. | LYY | Class I | |
| K002175 | Non-Sterile Powder Free Bubble-Gum Scented Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or | Sgmp Co., Ltd. | LYY | Class I | |
| K002101 | Angiodynamics Abscession Biliary Drainage Catheter | Boston Scientific Corporation | FGE | Class II | |
| K001883 | Lifestyles, Contempo or Private Label Large Condom | Ansell Healthcare Products LLC | HIS | Class II | |
| K001798 | Dc Titan | Austenal, Inc. | EJH | Class II | |
| K001690 | Protectiv Safety Blood Collection Needle | Johnson & Johnson MEDICAL GmbH | FMI | Class II | |
| K001539 | Renu Multiplus Multi-Purpose Solution | Bausch & Lomb Incorporated | LPN | Class II | |
| K001533 | Surgiflator-40 | W.O.M. Gmhb | HIF | Class II | |
| K001515 | Pathway Cts 2000 Pelvic Floor Training System, Model Pathway Cts 2000 | The Prometheus Group | KPI | Class II | |
| K994161 | Synthes Bioresorbable Suture Anchor | Synthes (USA) Products LLC | MAI | Class II | |
| K002211 | Colleague Cx Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151 | Baxter Healthcare Corporation | FRN | Class II | |
| K001873 | Hemosafe Patient Connector for Fresenius Bloodlines, Model 04-9100-0 | Fresenius Medical Care Renal Therapies Group, LLC | FJK | Class II |