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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | ESW | Class II | |
| K251213 | Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | Innovasis, Inc | OLO | Class II | |
| K250716 | Image One | Infomed Software, S.L. | LLZ | Class II | |
| K250590 | MAGiC Sweep™ EP Mapping Catheter | Stereotaxis Inc | DRF | Class II | |
| K250280 | SD TL Implant System | ARUM DENTISTRY Co., Ltd. | DZE | Class II | |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | Edwards Lifesciences LLC | DQK | Class II | |
| K243681 | Neuro Insight V1.0 | Olea Medical S.A.S. | LLZ | Class II | |
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) | Vitrolife Sweden AB | MQF | Class II | |
| K242615 | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | Xiamen Taotao Technology Co., Ltd. | IRP | Class II | |
| K251638 | Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co.,Ltd. | INI | Class II | |
| K251616 | Clear Miracle | Ods Co., Ltd. | NXC | Class II | |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences, Inc. | JXI | Class II | |
| K251310 | Ots 25-L (100-5) | Ots-Medical | MBI | Class II | |
| K251300 | Plastic Surgical Kits | Dentsply Sirona Inc | KCT | Class II | |
| K251255 | LymphaTech Mobile 3D Measuring Tool | Lymphatech | SFG | Class I | |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K250686 | GyriCalc (Version 1.0.0) | Neurospectrum Insights Corp. | LLZ | Class II | |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | MQB | Class II | |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd | KNW | Class II | |
| K243566 | CardioTag™ | Cardiosense, Inc. | DXR | Class II | |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab, Inc. | OWB | Class II | |
| K243425 | Guided DAS Surgical Kit | Talladium Espana, SL | KCT | Class II | |
| K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | FRO | Unclassified | |
| K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies | PBP | Class II | |
| K251564 | microINR System | Iline Microsystems S.L. | GJS | Class II | |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | OBJ | Class II | |
| K252218 | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | NFO | Class II | |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Corp. | HIH | Class II | |
| K251906 | Z1 Hip System | Zimmer GmbH | LZO | Class II | |
| K251809 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences, Inc. | OWW | Class II | |
| K251585 | Profoject™ Enteral Feeding Syringe | CMT Health Pte. Ltd. | PNR | Class II | |
| K251542 | InstaFAN | Onepass Medical Ltd | ODG | Class II | |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K250952 | Baby Gorilla®/Gorilla® Plating System | Paragon 28 | HRS | Class II | |
| K250902 | HeartFlow Analysis | Heartflow, Inc. | PJA | Class II | |
| K250750 | Innovision-P5 | DK Medical Systems Co., Ltd. | IZL | Class II | |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | OBO | Class II | |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay LLC | ITH | Class II | |
| K243404 | HyHub™ and HyHub™ Duo Vial Access Devices | Takeda Pharmaceuticals | LHI | Class II | |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-NX Co., Ltd. | EBW | Class I | |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | MQV | Class II | |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | EIA | Class I | |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences, Inc. | JXI | Class II | |
| K251016 | MectaLIF 3D Metal | Medacta International SA | MAX | Class II | |
| K250751 | DualView Catheter | Terumo Corp. | DQO | Class II | |
| K243756 | 0.014” Willow Guidewire | Arbor Endovascular | MOF | Class II |