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 |
|---|---|---|---|---|---|
| K994265 | Medisana Digital TENS | FUJI Dynamics Limited | GZJ | Class II | |
| K993527 | Loop Electrode, Ball Electrode | Palm Medical USA, Inc. | HGI | Class II | |
| K001894 | Modification to E-Scan | Esaote North America, Inc | LNH | Class II | |
| K001789 | Seamguard Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | OXD | Class II | |
| K001772 | Laserex Era Articulated Arm Kit, Model Lqp4106-Aa | Taracan Pty., Ltd. | HQF | Class II | |
| K001756 | Lunar Report Generator II | Lunar Corp. | KGI | Class II | |
| K001596 | Liferx | Bowdengs Technologies, LLC | LLZ | Class II | |
| K001334 | Hitachi Airis II | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K001129 | Prolong, Models Pl50, Pl100, Pl150 | Life-Tech Intl., Inc. | CAZ | Class II | |
| K994404 | Instant-View Morphine Urine Cassette Test | Alfa Scientific Designs, Inc. | DPK | Class II | |
| K983667 | Ionics Levante Intervertebral Pillar, Expandable | Ionics Medical Corp. | MQP | Class II | |
| K981089 | Tissomat and Spray Set | Baxter Healthcare Corporation | FMF | Class II | |
| K001845 | Mallinckrodt, Goodknight 418S | Mallinckrodt Developpement France | BZD | Class II | |
| K001770 | Bci M4529a Oem Digital Handheld Oximeter, Model M4529a | Bci, Inc. | DQA | Class II | |
| K001758 | Dade Tru-Liquid Moni-Trol Chemistry Control Levels 1, Mid, 2, and S (Assayed) | Medical Analysis Systems, Inc. | JJY | Class I | |
| K001715 | Powdered Patient Examination Gloves, Latex | Fitco Dipped Products Pvt., Ltd. | LYY | Class I | |
| K001518 | Gradia | GC America Inc. | EBF | Class II | |
| K001469 | R&d Project Dw269#25 | Ivoclar North America, Inc. | EJS | Class II | |
| K001432 | Disposable PVC Synthetic Exam Gloves, Powder Free | Shanghai PM Plastics Ent. Co., Ltd. | LYZ | Class I | |
| K001430 | Respirtech Pro-O2c, Model 2200 and Respirtech Pro, Model 2000 | Vortran Medical Technology 1, Inc | BTL | Class II | |
| K001418 | Aluminum Oxide Powder, Sumicorundum Aao4s | Procera Sandvik, Inc. | EIH | Class II | |
| K001383 | Supremcast V | American Dent-All, Inc. | EJH | Class II | |
| K001337 | Daniels Sharpsmart Reusable Sharps Container | Daniels Corporation Pty, Inc. | MMK | Class II | |
| K001218 | Correct Plus | Jeneric/Pentron, Inc. | ELW | Class II | |
| K001165 | Polymer Coated Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | Medipure Corporation (M) Sdn. Bhd. | LYY | Class I | |
| K001137 | Aerotrach Plus Valved Holding Chamber (Vhc) | Trudell Medical Intl. | CAF | Class II | |
| K001117 | Comfort Stim | R & D Medical Products, Inc. | GXY | Class II | |
| K001110 | Crystal-EEG Model 15 | Cleveland Medical Devices, Inc. | OMC | Class II | |
| K000901 | Klinidrape Surgical Gowns, Non-Reinforced, Basic Protections and Standard Protection | Molnlycke Health Care | FYA | Class II | |
| K993741 | Ez Ldl Cholesterol Test System | Sigma Diagnostics, Inc. | MRR | Class I | |
| K001848 | Omron Intellisense Blood Pressure Monitor, Model Hem-907 | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K001235 | Opti-Free Supraclens Daily Potein Remover / Rgp Multi-Purpose Disinfecting Solution Id 100136 | Alcon Universal, Ltd. | MRC | Class II | |
| K001135 | 6F & 7F Introducing Catheters (Modification) | Cordis US Corp. | DYB | Class II | |
| K000586 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems | JGY | Class I | |
| K994130 | Rectosight Rs 300-04 | Sightline Technologies, Ltd. | FER | Class II | |
| K001888 | Unicorn Model Sys0630 | Danish Diagnostic Development A/S | KPS | Class II | |
| K001862 | Synthetic Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | LYZ | Class I | |
| K001834 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | LYZ | Class I | |
| K001801 | Steathstation Treatment Guidance Platform | Medtronic Surgical Navigation | HAW | Class II | |
| K001787 | Quart Arterial Filter, Model Hbf 140 | Jostra Medizintechnik AG | DTM | Class II | |
| K001776 | Modification to Hp M2376a Device Link System, Model M2376a | Agilent Technologies, Inc. | MWI | Class II | |
| K001722 | Agilent Component Monitoring System; Agilent Invasive Blood Pressure Module | Agilent Technologies Deutschland GmbH | MHX | Class II | |
| K001688 | Datex-Ohmeda Tuffsat 3000 Pulse Oximeter | GE Healthcare | DQA | Class II | |
| K001682 | Vscore with EKG Signal Gating | Canon Medical Informatics, Inc. | JAK | Class II | |
| K001674 | Powder-Free Latex Examination Gloves-Blue Color | Pamitex Industries Sdn Bhd | LYY | Class I | |
| K001671 | Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630 | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K001664 | Compact Portable Patient Monitor with Wireless Alan, Model Alilent M3000a/m3046a Option J120 | Agilent Technologies, Inc. | MHX | Class II | |
| K001611 | Disposable PVC Synthetic Examination Gloves, Powder Free | Shanghai PT Plastics Enterprise Company, Ltd. | LYZ | Class I | |
| K001322 | Performer 30 Hps | Cornelia Damsky, Inc. | GEX | Class II |