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 |
|---|---|---|---|---|---|
| K083746 | Biosign Flu A+b | Princeton BioMeditech Corp. | PSZ | Class II | |
| K103041 | Vacuette Blood Collection Tube with Lithium Heparin and Gel Separator | Greiner Bio-One North America, Inc. | JKA | Class II | |
| K103007 | Affiniti Total and Hemi-Shoulder System | TORNIER Inc. | KWS | Class II | |
| K103003 | Aesculap- Meithke Progav Programmable Shunt System | Aesculap Inc | JXG | Class II | |
| K102988 | Electronic Blood Presure Monitor | Shenzhen Pango Electronic Co., Ltd. | DXN | Class II | |
| K102666 | Kimberly-Clark Surgical Drapes with AAMI Liquid Barrier Level 4 Claim | Kimberly-Clark Corporation | KKX | Class II | |
| K102484 | Sequre Snare System | Lifetech Scientific (Shenzhen) Co,.ltd | MMX | Class II | |
| K102344 | Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T Mr Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K102245 | Care Zy5ba Oxygen Concentrator | Foshan Care Medical Technology Co., Ltd. | CAW | Class II | |
| K102215 | Kirschner Wires, Steinman Pins | Evergreen Orthopedic Research Lab | HTY | Class II | |
| K102048 | Atraumatic Vascular Clamps | Geomed Medizin-Technik GmbH & Co. KG | DXC | Class II | |
| K101400 | Locking Compression Plate | Changzhou Orthmed Medical Instrument Co., Ltd. | HRS | Class II | |
| K101382 | Dpl Nuve | LED Technologies, Inc. | OHS | Class II | |
| K101321 | Ematrix CO2 | Syneron Medical, Ltd. | GEX | Class II | |
| K101183 | Modification to: Oasys System | Howmedica Osteonics Corp | KWP | Class II | |
| K092541 | Interface | Biostructures, LLC | MQV | Class II | |
| K092258 | Randox Metabolite (Eddp) Assay | Randox Laboratories, Limited | DJR | Class II | |
| K102581 | Defendo Disposable Suction Valve Model 100305 | Byrne Medical, Inc. | ODC | Class II | |
| K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/extended Offset, Plasma Coated, Press-Fit, Size 19/20 | Exactech, Inc. | LZO | Class II | |
| K102354 | Grandio So Heavy Flow | Voco GmbH | EBF | Class II | |
| K102337 | Synthetic Vinyl Examination Gloves, Powder Free | Curon Scientific Co Ltd | LYZ | Class I | |
| K102073 | Med-Rx Transfer Set, Models 10-1227Ts, 10-1300Ts, 10-1305Ts and 10-1306Ts | Canadian Hospital Specialties Ltd. | FPA | Class II | |
| K101943 | Synthetic, Powder-Free Nitrile Examination Gloves | Tangshan Jiteng Plastic Products Co., Ltd. | LZA | Class I | |
| K101808 | Shapeloc-Cl (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-St (Tenodesis) Soft Tissue Fastner | Medshape, Inc. | HWC | Class II | |
| K101582 | Cam Structsure Bars | ZimVie US Corp LLC | NHA | Class II | |
| K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | LPH | Class II | |
| K102820 | Appliance, Fixation, Spinal Intervertebral Body | Alphatec Spine, Inc. | KWQ | Class II | |
| K102757 | Lifenet System | Physio Control, Inc. | MSX | Class II | |
| K102527 | Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip; Imager II Urology Torque Catheter | Boston Scientific Corporation | KOD | Class II | |
| K102393 | Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System | GE Medical System Israel, Ltd. | IYO | Class II | |
| K102198 | Compact Touch Sts | Quantel Medical | IYO | Class II | |
| K102067 | Endoskeleton to | Titan Spine, LLC | MAX | Class II | |
| K101538 | Handheld Manual Breast Pump (Avent Manual Breast Pump) | Philips Electronics UK Limited | HGY | Class I | |
| K101519 | Parietex Plug and Patch | Sofradim Production | FTL | Class II | |
| K101220 | Explorer 4D Treatment Planning System | American Radiosurgery, Inc. | MUJ | Class II | |
| K100407 | Life Spine Interspinous Fixation System | Life Spine | MNI | Class II | |
| K102967 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2 | Smith & Newphew, Inc. | OLO | Class II | |
| K102953 | Heparin Dose Response Cartridge | Medtronic, Inc. | JOX | Class II | |
| K102951 | Exactech Equinox Fixed Angle Replicator Plate (0Mm,1.5mm,4.5mm), Humeral Head-Short (44Mm,47mm), Glenosphere (38Mm,42mm) | Exactech, Inc. | PHX | Class II | |
| K102631 | Kd-931D Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K102500 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating | Medtronic, Inc. | KGO | Class I | |
| K102409 | Defendo Disposable Air/water Valve Model 100304 | Byrne Medical, Inc. | ODC | Class II | |
| K102388 | Vivid I Diagnostic Ultrasound System | GE Medical System Israel, Ltd. | IYN | Class II | |
| K102200 | Integrity Model 1014284 | Elekta Limited | IYE | Class II | |
| K101112 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | KWP | Class II | |
| K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector | Kawasumi Laboratories Co., Ltd. | FMI | Class II | |
| K102930 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K102865 | Dc-7 Diagnostic Ultrasound System, Dc-3/Dc-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | ITX | Class II | |
| K102646 | Spider Flex Monopolar Hook | Asensus Surgical, Inc. | GCJ | Class II | |
| K102478 | OTC Elasto-Gel Manuka Honey Wound Dressing | Southwest Technologies Inc | FRO | Unclassified |