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 |
|---|---|---|---|---|---|
| K973693 | Aqua Patch | Pci Technology | MGQ | Unclassified | |
| K973682 | Bipolar Arthroscopic Probe, Straight, Biopolar Arthroscopic Probe, Angled, Bipolar Arthroscopic Probe, Straight, | Electroscope, Inc. | GEI | Class II | |
| K973672 | Foundation Plasma Sprayed Metal-Backed Patella | Encore Orthopedics, Inc. | JWH | Class II | |
| K973614 | Foundation Unipolar Femoral Head with Modular Neck Length Sleeves | Encore Orthopedics, Inc. | KWL | Class II | |
| K973609 | Ida-4 and Ipt-Mc | Bio-Tek Instruments, Inc. | FRN | Class II | |
| K973284 | Cobas Integra Hdl-Cholesterol Direct | Roche Diagnostic Systems, Inc. | CHH | Class I | |
| K971900 | Lateral Flare Internal Collar (Lfic) | Pro-Lfic, LLC | LWJ | Class II | |
| K971818 | Snorex | Snorex (Nz), Ltd. | LQZ | Class II | |
| K970795 | Shang Ho | Shang HO Industrial Corp., Ltd. | KGO | Class I | |
| K970465 | Bouser's Urinal | General Polymers | EXJ | Class I | |
| K974452 | Vigil Lipid Control | Beckman Instruments, Inc. | JJY | Class I | |
| K974421 | Elecsys Ck-Mb Stat | Boehringer Mannheim Corp. | JHY | Class II | |
| K974337 | Il Test Urea Nitrogen | Instrumentation Laboratory Co. | CDQ | Class II | |
| K974197 | Elite Lightweight Wheelchair | Jaken Co., Inc. | IOR | Class I | |
| K974182 | Powdered Nitrile Examination Gloves (Blue Colour) | Sri Johani Sdn. Bhd. | LZA | Class I | |
| K974131 | Alert | Jeneric/Pentron, Inc. | EBF | Class II | |
| K974125 | Il Test Amylase | Instrumentation Laboratory Co. | JFJ | Class II | |
| K974120 | Powder-Free Vinyl Patient Examination Gloves | Shanghai Super Gloves Co., Ltd. | LYZ | Class I | |
| K974089 | Alloy Primer | Kuraray America, Inc. | KLE | Class II | |
| K974035 | Century Alloy | Dentsply Intl. | EJJ | Class II | |
| K974014 | Pulpdent Dentastic Uno | Pulpdent Corporation | EMA | Class II | |
| K974013 | Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and 0.2 U Filter, Extension Set with Microbore | Sims Deltec, Inc. | FPA | Class II | |
| K973961 | 3M Dent System II Plus | 3M Company | EMA | Class II | |
| K973957 | Dbest One-Step Hcg Serum/urine Test | Ameritek, Inc. | JHI | Class II | |
| K973904 | Polymer Latex Examination Gloves | Sri Johani Sdn. Bhd. | LYY | Class I | |
| K973903 | Powderfree Nitrile Examination Gloves (Blue Colour) | Sri Johani Sdn. Bhd. | LZA | Class I | |
| K973793 | Olicon Imaging Systems, Inc. Gateway And/or Software | Olicon Imaging Systems, Inc. | LMD | Class I | |
| K973773 | Dapelle Hair Remover | Wellquest Intl., Inc. | KCX | Class I | |
| K973755 | Pilot Tube Repair Kit | Instrumentation Industries, Incorporated | BSK | Class II | |
| K973717 | Combiderm Acd | Convatec, A Bristol-Myers Squibb Co. | FRO | Unclassified | |
| K973716 | Duoderm Extra Thin Cgf Dressing | Convatec, A Bristol-Myers Squibb Co. | FRO | Unclassified | |
| K973659 | Vasocor Pvr 100 | Vasocor, Inc. | JOM | Class II | |
| K973648 | Mini Forceps with HF, 3.5Mm; Micro Forceps with HF, 2Mm | Richard Wolf Medical Instruments Corp. | GEI | Class II | |
| K973621 | Pre-View Cholangiography Clamp | Nashville Surgical Instruments | GBZ | Class I | |
| K973620 | Vacuette Multi-Sample Needle | Greiner Meditech, Inc. | FMI | Class II | |
| K973594 | Gore Resolut Xt Regenerative Material | W. L. Gore & Associates, Inc. | LYC | Class II | |
| K973540 | Elekta Oncology Systems Icom/quickmode Software Options | Elekta Oncology Systems, Ltd. | IYE | Class II | |
| K973537 | Pathway Electromyograph | The Prometheus Group | HCC | Class II | |
| K972854 | Protos i.v. Administration Set (15 Drops/ml) I4070s/(60 Drops/ml)i4670s Preliminary | Globe Ent., Inc. | FPA | Class II | |
| K972839 | Protos 100Ml Burette Infusion Set/ Protos 150Ml Burette Infusion Set | Globe Ent., Inc. | FPA | Class II | |
| K972634 | Ultracell Suction Sponge | Ultracell Medical Technologies, Inc. | GDY | Class I | |
| K972633 | Ultracell Suction Sponge | Ultracell Medical Technologies, Inc. | HOZ | Class II | |
| K972198 | Dent-Temp Acrylic | Health-Dent Intl., Inc. | EBG | Class II | |
| K972192 | Perception Inc. Gps-Xyz Diagnostic Ultrasound System | Perception, Inc. | IYO | Class II | |
| K972081 | Superskin | Medlogic Global Limited | NEC | Class I | |
| K971944 | Lactest I | Jwt, Inc. | KHP | Class I | |
| K971790 | Knoll/midus (Male Impotence Diagnostic Ultrasonic System) | Urometrics, Inc. | IYN | Class II | |
| K971242 | Blink Gold Evelid Weight (Bg 06 Thru Bg 28) | Ipax, Inc. | MML | Class II | |
| K970727 | Mport Foldable Lens Placement System | Chiron Vision Corp. | MSS | Class I | |
| K970367 | Thermo-Stat System | Aquarius Medical Corp. | DWJ | Class II |