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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K853300 | Healthdyne Impluse Ventilator | Healthdyne, Inc. | CBK | Class II | |
| K853296 | Emodren Guide Needle for Drainage Tube & Emodren | Parexel Intl. Corp. | BYY | Class II | |
| K852646 | Thermatic Suction Pump | H.C.H. Products, Inc. | BTA | Class II | |
| K852584 | Porous Apf/collarless Modular Femoral Component | Zimmer GmbH | KWL | Class II | |
| K852261 | Ysi Model 2372 Total Blood Lactate Kit | Yellow Springs Instrument Co., Inc. | KHP | Class I | |
| K850818 | Co 2 Surgical Laser System Na-120 | Xanar, Inc. | GEX | Class II | |
| K850805 | Co 2 Surgical Laser System Model Na-40 | Xanar, Inc. | GEX | Class II | |
| K850804 | Co 2 Surgical Laser System Na-30 | Xanar, Inc. | GEX | Class II | |
| K850382 | Iridium Seeds | Radiation Safety & Nuclear Products, Inc. | IWA | Class II | |
| K850289 | Monarch Sterilization Container System | Monarch Products, Inc. | FRG | Class II | |
| K852827 | Cordis External Neural Stimulator Model 911A | Cordis US Corp. | GZB | Class II | |
| K852707 | Gastro-Enterostomy Tube | Medical Innovations, Inc. | KNT | Class II | |
| K852549 | Sonoranger | Ausonics Pty, Ltd. | IYO | Class II | |
| K851982 | Kitecko Ultrasound Standoff Pad | 3M Company | IYO | Class II | |
| K851000 | Cooper Lasersonics 880 Co2/nd:yag Medical Laser Sy | Cooper Lasersonics, Inc. | GEX | Class II | |
| K850137 | Teca Tc2-64 Transcranial Doppler | Teca, Inc. | DPW | Class II | |
| K844173 | Femtest | Bionexus, Inc. | HES | Class II | |
| K853246 | Calcium Chloride | Bio/Data Corp. | JPA | Class II | |
| K853187 | Acridine Orange Fluorescent Stain | Advanced Medical Technology, Inc. | IDC | Class I | |
| K853184 | Piggymate i.v. Tubing Lock | Trend Medical, LLC | FPA | Class II | |
| K853177 | Ecumol Ultraviolet Suntannning Beds | Mottek Intl. Corp. | FTC | Class II | |
| K853081 | Auramine O Fluorescent Mycobacterial Stain Set | Advanced Medical Technology, Inc. | KJK | Class I | |
| K853005 | S.s. White Dental X-Ray Film Holder & Aligning Arm | The S. S. White Co. | EGZ | Class I | |
| K852843 | General Diagnostics Coag-a-Mate Xc | Warner-Lambert Co. | KQC | Class I | |
| K852705 | Lidgren-Lund Femoral Dysplasia Hip Prosthesis Sys | Waldemar Link GmbH & Co. KG | JDI | Class II | |
| K852665 | Syncor Trich Direct Immunofluorescence Assay | Syncor Intl. Corp. | JWZ | Class I | |
| K852650 | Oxymatictm Electronic Oxgyen Conserver | Chad Therapeutics, Inc. | NFB | Class II | |
| K852492 | Coagulator | Med USA | KQG | Class II | |
| K852314 | #6010 Non-Conductive Ventilator Circuit | Sigma Medical, Inc. | CAI | Class I | |
| K852225 | Believe Deodorant Labial Pads | Kimberly-Clark Corporation | HHL | Class II | |
| K852144 | Sierra -Oxygen Concentrate | Mountain Medical Equipment, Inc. | CAW | Class II | |
| K852031 | Endoport 5Mm | Endotherapeutics | HET | Class II | |
| K852025 | Brandt Tracheal Tube(tentative) | Mallinckrodt Critical Care | BTR | Class II | |
| K851225 | Urine Duo | Culture Kits, Inc. | JTZ | Class II | |
| K850395 | The Fever-Therm a Therm. Measuring Device | Kma, Inc. | FLL | Class II | |
| K853244 | Total Protein Reagent for Astra 8 Stat/rou Analyze | Simmler Inc | CEK | Class II | |
| K853203 | Ultraclone Ecl-01-2200 Cell Line | Earl-Clay Laboratories, Inc. | KIR | Class I | |
| K853168 | Malis Bipolar Pen | Valley Forge Scientific Corp. | GEI | Class II | |
| K853113 | Td Tricyclic Antidepressants | Abbott Medical | LFG | Class II | |
| K853078 | Citrex III | Bio/Data Corp. | JPA | Class II | |
| K853077 | Citrex II | Bio/Data Corp. | JPA | Class II | |
| K853076 | Citrex I | Bio/Data Corp. | JPA | Class II | |
| K853041 | Triglycerides Lck 124 | German American Chamber of Commerce, Inc. | CDF | Class I | |
| K852995 | Endab Phenobarbital | IMMUNOTECH s.r.o. | DLZ | Class II | |
| K852902 | Metallic Sunglasses | Yours Enterprise Co., Ltd. | HQY | Class I | |
| K852835 | Ceftazidime 30 Mcg Sensitvity Discs | Difco Laboratories, Inc. | JTN | Class II | |
| K852747 | Visidex II Reagent Strips | Miles Laboratories, Inc. | |||
| K852683 | Electrosurgical Lateral Release Probe Mod Alr-100 | American Bentley | GEI | Class II | |
| K852638 | Humphrey Image Analyzer Model 110 | Zeiss Humphrey System | HKI | Class II | |
| K852610 | Hot Pack | Oriental Medical Supplies, Inc. | IMD | Class I |