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 |
|---|---|---|---|---|---|
| K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | QHE | Class II | |
| K233761 | Orthopaedic Surgery Planning Software (AIJOINT) | Longwood Valley Medical, Ltd. | LLZ | Class II | |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | Peregrine Surgical, LLC. | MPA | Class II | |
| K233577 | Sleepio® | Big Health Inc | QVO | Class II | |
| K242008 | Coronis OneLook | Barco N.V. | PGY | Class II | |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co.,Ltd. | HIH | Class II | |
| K241970 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) | Kanglongda Vietnam Protection Technology Company Limited | LZA | Class I | |
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. | JHI | Class II | |
| K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | LCJ | Unclassified | |
| K241892 | Cortera™ Spinal Fixation System | Xtant Medical Holdings, Inc. | NKB | Class II | |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., dba Stryker Orthopaedics | JDI | Class II | |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser) | Beijing Mega Beauty Technology Co.,Ltd. | GEX | Class II | |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Intuitive Surgical, Inc. | GEI | Class II | |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | Baxter Healthcare Corporation | MQV | Class II | |
| K241359 | Medline UNITE® MIS Foot Recon Screw System | MEDLINE INDUSTRIES, LP - Northfield | HWC | Class II | |
| K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) | Bernhard Förster GmbH | MQC | Unclassified | |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical, LLC | BZE | Class II | |
| K241181 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | Class II | |
| K240981 | Air compression leg massager | Huizhou Xinyi Technology Co., Ltd | IRP | Class II | |
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | QDA | Class II | |
| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences LLC | QMS | Class II | |
| K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | KDI | Class II | |
| K233706 | Bendini Cloud Application | NuVasive Inc | OLO | Class II | |
| K233601 | Fixone Meniscal Repair | Aju Medical Co., Ltd. | MBI | Class II | |
| K233571 | GCI Surgical Gown | George Courey Inc | FYA | Class II | |
| K233534 | Viral Transport Medium | Hardy Diagnostics | JSM | Class I | |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, Inc. | IPF | Class II | |
| K242055 | Freefix Forearm Plating System | Skeletal Dynamics, Inc | HRS | Class II | |
| K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | JWH | Class II | |
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) | Karl Storz SE & Co. KG | FGB | Class II | |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty Limited | MEH | Class II | |
| K241238 | LOOP™ LED Curing Light System (CLK01) | Garrison Dental Solutions | EBZ | Class II | |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | Argon Medical Devices, Inc | DYB | Class II | |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix LLC | FRA | Class II | |
| K241137 | Clear Moves Aligner | Clear Moves Aligners | NXC | Class II | |
| K241105 | 3MP Color LCD Monitor (CL-S301) | JVCKENWOOD Corporation | PGY | Class II | |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | HIR | Class II | |
| K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | MHX | Class II | |
| K240301 | MammoScreen® (3) | Therapixel | QDQ | Class II | |
| K240035 | TACTIX Vector Syndesmosis System | Vilex LLC | HTN | Class II | |
| K234141 | AISAP Cardio V1.0 | Aisap | POK | Class II | |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) | PENTAX of America, Inc. | FDT | Class II | |
| K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K233731 | CardIQ Suite | GE Medical Systems SCS | JAK | Class II | |
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | DePuy Synthes | HSB | Class II | |
| K233580 | A Breathing System (ABS) | Deepwell Dtx, Inc. | HCC | Class II | |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | EZL | Class II | |
| DEN230046 | PGDx elio plasma focus Dx | Personal Genome Diagnostics Inc. | SBY | Class II | |
| K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | Anx Robotica Corp. | QKZ | Class II | |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | ETN | Class II |