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 |
|---|---|---|---|---|---|
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | Cook Ireland Ltd. | FGE | Class II | |
| K233043 | Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. | HEX | Class II | |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | Contec Medical Systems Co., Ltd. | KNG | Class II | |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems Inc | PSY | Class II | |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| K230668 | Disposable High-pressure Extension Lines | Precision Medical Plastics, Ltd. | DXT | Class II | |
| K241499 | 21.3” 5MP Color LCD Display UMD5-21B01 | Acula Technology Corp | PGY | Class II | |
| K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) | Abbott Medical | DYB | Class II | |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E | Sun Pharmaceutical Industries, Inc. | GEX | Class II | |
| K240815 | Arthrex Cannulated Screw System | Arthrex GmbH | HWC | Class II | |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | FMD Co., Ltd. | DQX | Class II | |
| K240149 | Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | |
| K240017 | InMode System with the Morpheus8 90 Applicator | Inmode Ltd. | GEI | Class II | |
| K233925 | Relu Creator | Relu BV | QIH | Class II | |
| K233892 | 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) | Zhuhai Dipu Medical Technology Co., Ltd. | GCJ | Class II | |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K233662 | Radiography 7300 C | Philips Medical Systems DMC GmbH | KPR | Class II | |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation | FDA | Class II | |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | |
| K232930 | Verve | Oculomotor Technologies | SBN | Class I | |
| K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | LBH | Class II | |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | DTZ | Class II | |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International SA | PML | Class II | |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | JOJ | Class II | |
| K240876 | Identity Shoulder System | Zimmer GmbH | MBF | Class II | |
| K240516 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | FAS | Class II | |
| K240256 | Remunity System | Deka Research & Development Corp. | QJY | Class II | |
| K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | Biosense Webster Inc | OBJ | Class II | |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K233266 | Mediblu ECG System | Mediblu Medical, LLC | DPS | Class II | |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGEND | Ami, Inc. | GEX | Class II | |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | bioMerieux, Inc. | NGZ | Class II | |
| K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle | Perfect Medical Industry (VN) Co., Ltd | FMF | Class II | |
| K241344 | MetriCide™ OPA Plus Solution Test Strip | STERIS Corporation | JOJ | Class II | |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | LIT | Class II | |
| K241011 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | |
| K232749 | Doopang | Ybrain Inc. | PCC | Class II | |
| K230546 | Signex | Osteonic Co., Ltd. | HRS | Class II | |
| K221547 | InActiv Blue | Fertipro N.V. | QBD | Class II | |
| DEN230069 | Mi-CHORD System | Lsi Solutions Inc. | SBK | Class II | |
| K241399 | Indigo® Lightning Flash Aspiration System – Select +™ Catheter | Penumbra Inc. | QEW | Class II | |
| K240644 | Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co.,Ltd. | GEX | Class II | |
| K240283 | BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | Macrolux Medical Technology Co., Ltd. | FAJ | Class II | |
| K240206 | Venue Sprint | GE Healthcare | IYN | Class II | |
| K240111 | Venue | GE Healthcare | IYN | Class II | |
| K240108 | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) | Gymmax Technology Shenzhen Co., Ltd | GXY | Class II | |
| K240106 | Histofreezer V | Cryoconcepts LP | GEH | Class II | |
| K240053 | Venue Go | GE Healthcare | IYN | Class II |