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 |
|---|---|---|---|---|---|
| K052851 | Voyager Linux with Tactile Guidance System (Tgs) | Mako Surgical Corp. | HAW | Class II | |
| K052679 | Cliniqa Liquid Qc Bilirubin Controls Levels 1, 2 & 3; Cliniqa Linical Bilirubin Calibration Verifiers Levels a-E | Cliniqa Corporation | JJX | Class I | |
| K052530 | Seednet, Seednet Gold, Cryohit, Cryothera | Galil Medical Ltd. | GEH | Class II | |
| K052502 | Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K052033 | Vintage Zr | Shofu Dental Corp. | EIH | Class II | |
| K051826 | Betacone Hip Prosthesis System | Waldemar Link GmbH & Co. KG | LWJ | Class II | |
| K051722 | Tricos T | Baxter Healthcare Corporation | MQV | Class II | |
| K051713 | Jbaids Anthrac Detection System | Idaho Technology, Inc. | NHT | Class II | |
| K051620 | Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series | Better Water, Inc. | FIP | Class II | |
| K051578 | Immunalysis Cocaine/cocaine Metabolite Elisa for Oral Fluids | Immunalysis Corporation | DIO | Class II | |
| K051330 | Uvbiotek Models 3200B and 4000B | Medtek Lighting | FTC | Class II | |
| K051211 | Qms Zonisamide Reagents, Calibrators and Controls | Seradyn, Inc. | NWM | Class II | |
| K051149 | Meditech Model Abpm-04 | Meditech Kft. | DXN | Class II | |
| K051144 | Acetylcholine Receptor Ab (Arab)rra | Ibl-Hamburg GmbH | NST | Class II | |
| K050398 | Exactech Ziramic Zirconia 12/14 Femoral Heads | Exactech, Inc. | LZO | Class II | |
| K053042 | Medrad 1.5T Pelvic Imaging System Interface Device | Medrad, Inc. | MOS | Class II | |
| K053009 | Ge 0.35T Signa Ovation with Excite Mr System | GE Healthcare | LNH | Class II | |
| K052938 | Cr-Pro | Eradlink, Inc. | MQB | Class II | |
| K052899 | Ats Simulus Annuloplasty Band, Model 700Fc | Genesee BioMedical, Inc. | KRH | Class II | |
| K052853 | Tigecycline 15Ug Bbl Sensi-Disc | Becton Dickinson & Co | JTN | Class II | |
| K052618 | Imagecast Pacs | Idx Systems Corp. | LLZ | Class II | |
| K052565 | Ats Simulus Annuloplasty Ring, Model 700Ff | Genesee BioMedical, Inc. | KRH | Class II | |
| K052550 | Imc Surgical Gowns | Intl. Medsurg Connection, Inc. | FYA | Class II | |
| K052413 | Tuna System, Models 8909, 8929, 8930, 8934 | Medtronic, Inc. | KNS | Class II | |
| K052408 | Ez-Io | Teleflex Medical | FMI | Class II | |
| K052377 | Philips Disposable Spo2 Sensors Mii32a and M1133a. | Philips Medizin Systeme Boeblingen GmbH | DQA | Class II | |
| K052313 | Stimuplex Hns-12, Model 4892098 | Stockert GmbH | BXN | Class II | |
| K052169 | Imc Surgical Drapes | Intl. Medsurg Connection, Inc. | KKX | Class II | |
| K051929 | Giardia/cryptosporidium Chek | Techlab, Inc. | MHJ | Class II | |
| K051759 | Flexi-Lite, Model Fl-V1.2 | Performance Hyperbarics | CBF | Class II | |
| K051572 | Koko Legend | Pulmonary Data Services, Inc. | BZG | Class II | |
| K051568 | Cadd-Ms 3 Ambulatory Infusion Pump | Abbott Medical | FRN | Class II | |
| K051226 | Airlife Nasal Continuous Positive Airway Pressure (Ncpap) Sytem Driver | Cardinalhealth | BZD | Class II | |
| K051111 | Sentinel Uibc Liquid | Sentinel CH SpA | JQF | Class I | |
| K050024 | One Step Multiple Drugs of Abuse Assays | Guangzhou Wondfo Biotech Co., Ltd. | DIS | Class II | |
| K043367 | Glaid Ocular Electrophysiology Device | Lace Electronica S.r.l. | GWE | Class II | |
| K053084 | Sigma 5000 Series Imagic Ultrasound System | Kontron Medical Systems SAS | IYN | Class II | |
| K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K053053 | Pacp System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | Class II | |
| K053017 | Models Hrs-63-8 and Hrs-127-8 Shoulder Array Coils | Invivo Corporation | MOS | Class II | |
| K052971 | Stryker Spine Trio Spinal Fixation System | Howmedica Osteonics Corp | MNI | Class II | |
| K052969 | Slendertone Gymbody, Model 512-01 | Bio-Medical Research, Ltd. | NGX | Class II | |
| K052958 | Color Nio 2Mp, E-2320 C | Barco N.V. | LLZ | Class II | |
| K052950 | The Zimmer Tmt Trabecular Metal Vertebral Body Replacement System | Zimmer Trabecular | MQP | Class II | |
| K052931 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K052699 | Versa-Link Porcelain Bonding System | Sultan Chemists, Inc. | KLE | Class II | |
| K052624 | Inion Otps Biodegradable Distal Radius Plate | Inion Oy | HRS | Class II | |
| K052603 | Reprocessed Daig Livewire Electrophysiology Catheters | Alliance Medical Corp. | NLH | Class II | |
| K052537 | Catella Diagnostic Workstation, Version 4.0 | American Medical Sales, Inc. | LLZ | Class II | |
| K052518 | Piezosurgery | Piezosurgery S.r.l. | ELC | Class II |