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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K892921 | Patient Examination Gloves | Millimax Corp. | LYY | Class I | |
| K892781 | Antelope Brand Patient Examination Gloves | Liaoning-Usa Corp. | LYY | Class I | |
| K892728 | Ifa Sensibac Norfloxacin | Investigacion Farmaceutica S.A. de C.V. | JTN | Class II | |
| K892556 | Patient Examination Gloves (Latex) | Fabella Industries Sdn Bhd | LYY | Class I | |
| K892077 | Patient Examination Glove (Latex) | Forchic Corp. of USA | LYY | Class I | |
| K891429 | Patient Examination Gloves (Latex) | Wei Ming Industry Co., Ltd. | LYY | Class I | |
| K890722 | Adg Bone Biopsy System | American Design Group, Inc. | GDM | Class I | |
| K894981 | Medtronic Model 5455S Disposable Surgical Cable | Medtronic, Inc. | DSA | Class II | |
| K894267 | Opus Models 4033 and 4034 | Ela Medical, Inc. | DXY | Class III | |
| K893459 | Plasma Tfe Vascular Prosthesis (Alter. Package) | Medtronic, Inc. | DSY | Class II | |
| K892799 | 8 Fr Percutan Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | DSP | Class II | |
| K892798 | 9 Fr Percutan Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | DSP | Class II | |
| K892797 | 10 Fr Percutan Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | DSP | Class II | |
| K895235 | Various Disposable Surgical Garments | Protect Corp. of Indiana, Inc. | FYE | Class I | |
| K894801 | 30-Cs01, 30-Cs02, 30-Cs03 Control Syringes | Advance Medical Designs Inc | FMF | Class II | |
| K894609 | Mardx Lyme Disease Ifa (Igm) Test System | Mardx, Inc. | LSR | Class II | |
| K894566 | Maximum Cure Sealant with Fluoride | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K894391 | Pvs Dual Cure Veneer Bonding Kit | Jelenko Co. | KLE | Class II | |
| K894243 | Rmi Arterial Perfusion Cannula | Research Medical, Inc. | DQR | Class II | |
| K893767 | Disposable Latex Examination Gloves | Masif Healthcare Products Sdn. Bhd. | LYY | Class I | |
| K892126 | Mitek Anchor | Mitek Surgical Products, Inc. | JDR | Class II | |
| K891444 | Perry* Sterile X-Am* Gloves | Smith & Nephew Medical Ltd | LYY | Class I | |
| K891234 | Terufusion Three Way Stopcock | Terumo Medical Corp. | FMG | Class II | |
| K891193 | Medi-Trace Accu-Nate Device | Graphic Controls Corp. | FPA | Class II | |
| K895384 | California Comfort Four Wheel | Jubilee Scooters, Inc. | IQC | Class II | |
| K895192 | Spinocan(r) Continuous Spinal Tray | Burron Medical, Inc. | CAZ | Class II | |
| K895093 | Slt Contact Laser Systems | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K895003 | Milenia(tm) Prolactin (Mkpr1,5) | Siemens Healthcare Diagnostics Inc. | CFT | Class I | |
| K894919 | Nr5000 e.c.g. and Pulse Oximeter Monitor | Nirad, Ltd. | DRT | Class II | |
| K894913 | Da-100Hs | Fischer Imaging Corp. | JAA | Class II | |
| K894906 | Anesthesia Breathing Bags Sizes 1/2, 1,2,3 Liter | Med-Tek Corp. | BTC | Class I | |
| K894757 | T-Scope, Telemetric Precordial Stethoscope | Louisville Laboratories, Inc. | BZT | Class II | |
| K894735 | Asc-952 Physiological Amplifier | Astro-Med, Inc. | DRR | Class II | |
| K894605 | Delfia Free Thyroxine (Ft4) Kit | Pharmacia, Inc. | CEC | Class II | |
| K894530 | Fpr Theophylline Calibrator Kit | Colony Laboratories, Inc. | DLJ | Class II | |
| K894500 | Daig Electrophysiology Catheter | Daig Corp. | DRF | Class II | |
| K894429 | Modified Claims for Fef(tm) End-Tidal CO2 Detector | Fenem, Inc. | CCK | Class II | |
| K894424 | Devilbiss Model 7351 Series | Devilbiss Health Care, Inc. | BYE | Class II | |
| K894219 | Temp Bond Ne | Kerr Corporation (Danbury) | EMA | Class II | |
| K894169 | Biotel Microalbuminuria (Tm) | American Diagnostic Corp. | JIR | Class I | |
| K894073 | Inamed Pro-Tec Silicone Surgical Gloves | Inamed Development Co. | KGO | Class I | |
| K893728 | Pink Cassette Caddie | Medical Technique Instruments, Inc. | IXA | Class II | |
| K893716 | Volumetric Pump Solution Set for Flo-Gard 8000 | Baxter Healthcare Corporation | FPA | Class II | |
| K893703 | After Loading Device Kit | Medical Radiation Devices, Inc. | IWJ | Class I | |
| K893449 | Latex Examination Gloves | Lon Tai Chemical Industrial Co., Ltd. | LYY | Class I | |
| K893182 | Latex Examination Gloves | Higlo Rubber Products Sdn. Bhd. | LYY | Class I | |
| K893030 | Child Size - Filter Flex (Tm) | Life Design Systems, Inc. | CAH | Class II | |
| K892970 | Patient Examination Gloves (Latex) | Naturub Sdn. Bhd. | LYY | Class I | |
| K892968 | Tufftex Patient Exam Gloves | Thai Latex, Inc. | LYY | Class I | |
| K892610 | Patient Examination Gloves (Latex) | Pt. Indolex Karya Prakarsa | LYY | Class I |