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 |
|---|---|---|---|---|---|
| K950013 | Consensus(tm) Orthopedic Drill Bit | U.S. Medical Products, Inc. | HWE | Class I | |
| K946057 | Aqualarm Moisture Sensor Model P85000 | Pegasus Research Corp. | BYH | Class I | |
| K945685 | Karl Storz Telescope Bridges and Inserts, Adapters | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K945367 | Ciba Corning Acs Cortisol Immunoassay | Ciba Corning Diagnostics Corp. | CGR | Class II | |
| K945318 | Tetrad Model 6F, End-Viewing, Endocavity Probe, 4.5/8.5 Mhz, Ca | Tetra Corp. | ITX | Class II | |
| K944736 | Vsp (Variable Screw Placement) | Acromed Corp. | MNH | Class II | |
| K944330 | Acutrak Plus Fixation System | Acu Med, Inc. | HWC | Class II | |
| K944265 | Needle Elctrode | Unimed Surgical Products, Inc. | GEI | Class II | |
| K942820 | H292 | Bartels, Inc. | KIR | Class I | |
| K942725 | Cmi Velvet Touch Vacuum Extractor | Columbia Medical & Surgical, Inc. | HDB | Class II | |
| K942504 | Instaspot | Fidelity Medical, Inc. | LLZ | Class II | |
| K941608 | Integral Omniloc Dental Implant with Interface Ring | Calcitek, Inc. | DZE | Class II | |
| K935755 | The Ultra | Medical Device Systems, Inc. | KCT | Class II | |
| K932742 | Ebna Igg Elisa Test System | Zeus Scientific LLC | LLM | Class I | |
| K932031 | Ambu Portable Suction Unit | Ambu, Inc. | BTA | Class II | |
| K931490 | Slt Multidimensional Contact Laser System Family | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | IYE | Class II | |
| K951744 | Large Tip (4Mm) Diagnostic-Electrohysiology Catheters | Boston Scientific Corporation | DRF | Class II | |
| K951503 | Cvd Bullett Hi-Flo Infusion Catheter | Cardiovascular Dynamics, Inc. | KRA | Class II | |
| K951372 | Philips Gallileo Automatic Collimator (or Beam Limiting Device) | Philips North America LLC | IZW | Class II | |
| K951146 | Imaging Table | Septa Corp. | KXJ | Class II | |
| K951005 | Kenex Injector Head Support (as Exhibit 2) | Kenex, Ltd. | IZQ | Class II | |
| K950502 | Ccd Endocam 5501 | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K950431 | Lossless Teleradiology Option for Use with Ies, Image Enhancement System | Open Mri, Inc. | LMD | Class I | |
| K946378 | Bcm 400Cp | B C Medical, Ltd. | IZI | Class II | |
| K945319 | Tetrad Model Bs18, Endosurgical Needle Guide Attachment | Tetra Corp. | ITX | Class II | |
| K944833 | Digitrace Sleep Computer, Sleeppac, Home Sleep System | New England Medical Monitoring Co. | OMB | Class II | |
| K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) | Endosonics Corp. | IYO | Class II | |
| K943156 | System, Image Processing | Image Technology, Inc. | JAA | Class II | |
| K940910 | Filtryzer | Toray Industries (America), Inc. | FJI | Class II | |
| K940013 | Body Position Indicator, Model Bpi1 | Pro-Tech, Inc. | MNR | Class II | |
| K933654 | Bladder Neck Support Prothesis Fitting Kit | Johnson & Johnson MEDICAL GmbH | HHW | Class II | |
| K933417 | Echomark(r) Electrophysiology Catheter | Echocath, Inc. | DRF | Class II | |
| K930618 | Vaginal Continence Device | Johnson & Johnson MEDICAL GmbH | HHW | Class II | |
| K922688 | Extra Protection Polyurethane Condom | Apex Medical Technologies, Inc. | MOL | Class II | |
| K921791 | Wallach Leap 100 Electro Surgery System | CooperSurgical, Inc. | HGI | Class II | |
| K951692 | Mist Endoscopic Probes | Mist, Inc. | GCJ | Class II | |
| K951589 | Manual Surgical Insrument | United States Surgical, A Division of Tyco Healthc | GEI | Class II | |
| K951527 | The Pilot Audiometer | American Electromedics Corp. | EWO | Class II | |
| K951481 | Mist Endoscopic Cannulas | Mist, Inc. | GCJ | Class II | |
| K951480 | Mist Trocars | Mist, Inc. | GCJ | Class II | |
| K951445 | Olympus Fd-5 Hot Biopsy Forceps | OLYMPUS Corporation of the Americas | KGE | Class II | |
| K951398 | Mist Reducer Sleeves | Minimally Invasive Surgical Technologies, Inc. | GCJ | Class II | |
| K951312 | Monoject Whitacre Point Spinal Needle (27G X 3 1/2) | Sherwood Medical Co. | BSP | Class II | |
| K951296 | Delton F Pit & Fissure Sealant | Dentsply Intl. | EBC | Class II | |
| K950992 | Ceramaflex Bracket System | TP Orthodontics, Inc. | NJM | Class II | |
| K950830 | Sta-Put Non-Magnetic Instrument Drape Catalog #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/dexter Wrap | Avail-Southwest Division | KKX | Class II | |
| K950788 | Otoscope a-34 | Neitz Instruments Company, Ltd. | ERA | Class I | |
| K950784 | Dristar Urinary Incontinence Management System | Advanced Bioresearch Assoc. | EYQ | Class I | |
| K950699 | Preview Teleimaging System | Regulatory Management Services | LMD | Class I |