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 |
|---|---|---|---|---|---|
| K981101 | Stratus Cs Myo Calpak | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K981051 | Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus with Holes | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K980991 | Nova Stat Profile Phox Blood Gas Analyzer | Nova Biomedical Corporation | CHL | Class II | |
| K980924 | Plancon Microlamellar Keratome Evolution | Plancon Instruments | HNO | Class I | |
| K980720 | Nonwoven Pad | Convatec, A Division of E.R. Squibb & Sons | KMF | Class I | |
| K980599 | Ntech Arthroscope | N-Tech Endoscopy, Inc. | GCJ | Class II | |
| K980537 | Nd: Yag Accessory for Photoderm System | Esc Medical Systems, Ltd. | GEX | Class II | |
| K980525 | Ubas Manual Method and Ubas Automated Method | Marukin Shoyu Co., Ltd. | KWX | Class II | |
| K980134 | Ksea N2o Endoflator | Karl Storz Endoscopy-America, Inc. | HIF | Class II | |
| K973562 | Imex Medical Systems, Inc. Imexlab 9100 | Imex Medical Systems, Inc. | IYN | Class II | |
| K971402 | Bard Bta Trak Test | Bard Diagnostic Sciences,Inc. | MMW | Class II | |
| K971157 | Macralp(a) Enzyme Immunoassay Kit | Strategic Diagnostics, Inc. | JHO | Class I | |
| K980605 | Low Protein Latex Patient Examination Gloves (Powder-Free) | Pt. Sarana Indoprotex | LYY | Class I | |
| K980589 | Ar Safe Nitrile Examination Gloves | Alliance Rubber Products Sdn. Bhd. | LZA | Class I | |
| K980543 | Denoptix Barrier Envelope (Size 0-4) | Dentsply Intl. | EHD | Class II | |
| K980513 | Articul/eze Femoral Heads | Depuy Orthopaedics Inc. | JDI | Class II | |
| K980496 | Wright Medical Technology Rod-to-Rod Coupler | Wrightmedicaltechnologyinc | MNH | Class II | |
| K980486 | Implex Hep Acetabular Revision Cup, Cemented or Cementless Model a-240 System | Implex Corp. | JDI | Class II | |
| K980447 | Depuy Motech Moss Miami Spinal System | Depuy Orthopaedics Inc. | MNH | Class II | |
| K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | Zimmer GmbH | KTT | Class II | |
| K980368 | Depuy Motech Peak 3Mm Fixation Rod System | Depuy, Inc. | HRS | Class II | |
| K980228 | University Plate Anterior System | Acromed Corp. | KWQ | Class II | |
| K974510 | Envoy Patient Monitor | Mennen Medical, Inc. | DSI | Class II | |
| K973613 | Ch-611B and Ch-611C Digital Wrist Sphygmomanometers Blood Pressure Meter | Foley & Lardner | DXN | Class II | |
| K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | MAI | Class II | |
| K972546 | Rusch Single Use Crystal Tracheostomy Tube Set | Rusch Intl. | JOH | Class II | |
| K972201 | Patch,pledget and Intracardiac,petp,ptfe,polypropylene | Sulzer Carbomedics, Inc. | DXZ | Class II | |
| K971400 | Muscle Response Monitor | Enriching Your Life | HCC | Class II | |
| K980695 | Fuji I | GC America Inc. | EMA | Class II | |
| K980474 | Telicam | Dental/Medical Diagnostic Systems, Inc. | EIA | Class I | |
| K980179 | Sharps Plus 5 Gallon Sharps Container | Rotonics Mfg., Inc. | FMI | Class II | |
| K980176 | Hispeed Qx/i CT Scanner System | General Electric Co. | JAK | Class II | |
| K980169 | Hispeed Lx//i, Hispeed Fx/i, and Hispeed Dx/i Family of Systems | General Electric Co. | JAK | Class II | |
| K980157 | Premier 7000 Ctl Spine Coil | GE Healthcare Coils | MOS | Class II | |
| K980147 | Your Choice Multi-Purpose Contact Lens Cleaning Solution | Automatic Liquid Packaging, Inc. | LPN | Class II | |
| K980503 | Temporary Cardiac Pacing Wire | Ethicon, Inc | LDF | Class II | |
| K980145 | Amt Decompression Tubes | Applied Medical Technology Inc | KGC | Class II | |
| K980110 | Endocre Cryocare Cryosurgical System | Varian Medical Systems, Inc. | GEH | Class II | |
| K980104 | Flow Rider Flow Directed Micro Catheter | Medtronic, Inc. | KRA | Class II | |
| K972647 | CO2 Pneumo-Dissector | Cook Incorporated | HET | Class II | |
| K971726 | Cv Peri-Guard - Cardiovascular Patch | Bio-Vascular, Inc. | DXZ | Class II | |
| K970961 | Vaporization Electrodes | Richard Wolf Medical Instruments Corp. | KNF | Class II | |
| K980768 | Vacuette Holdex | Greiner Meditech, Inc. | FMI | Class II | |
| K980617 | Modification to Reflex Aec Linear Stapler/cutter | Urohealth Systems, Inc. | GDW | Class II | |
| K980541 | Barco Mgd 521 5 Megapixel Diagnostic Display | Barco NV Display Systems | LMD | Class I | |
| K980472 | Kht Soft Needle, Acupuncture Needle | American Institute of Koryo Hand Therapy | MQX | Class II | |
| K980471 | Kht Guam Needle, Acupuncture Needle | American Institute of Koryo Hand Therapy | MQX | Class II | |
| K980451 | Bioderm Calcium Alginate Dressing | Bioderm, Inc. | KMF | Class I | |
| K980235 | Remote Hand Control to the Inflatable Positioning Cushion (A.k.a. Imageair) | Kci New Technologies, Inc. | IZH | Class II | |
| K980159 | Octyldent (2-Octyl Cyanoacrylate), 02A01 | Closure Medical Corp. | EMA | Class II |