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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K223497 | Spectrum Saliva Collection Device | Spectrum Solutions LLC | QBD | Class II | |
| K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation | FGB | Class II | |
| K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip | Macromedics BV | IYE | Class II | |
| K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | Smith & Nephew, Inc. | MBI | Class II | |
| K222695 | troCarWash™ System | Biotex, Inc. | OCX | Class II | |
| K222588 | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 | Iweecare Co., Ltd. | FLL | Class II | |
| K222226 | Eon | Dominion Aesthetic Technologies, Inc. | PKT | Class II | |
| K221645 | PROstep(TM) MIS 5mm Chamfer Screw System | Wright Medical Technology Inc | HWC | Class II | |
| K221513 | Equashield Closed System Transfer Device | Equashield Medical Ltd | ONB | Class II | |
| K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | CAC | Class II | |
| K221043 | Doctor Tecar Plus, Doctor Tecar Smart | Mectronic Medicale S.r.l. | PBX | Class II | |
| K220276 | Infrared Thermometer TET-351 | Truly Instrument Limited | FLL | Class II | |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | ODP | Class II | |
| DEN210022 | Pmd-200 | Medasense Biometrics Ltd. | QVE | Class II | |
| K230118 | Bony Trauma Extremity System (BTES) Screw Range, NX Nail | Field Orthopaedics | HWC | Class II | |
| K223832 | Vivid S60N, Vivid S70N | GE Medical System Ultrasound and Primary Care Diagnostics | IYN | Class II | |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Stryker Corp. | LFL | Unclassified | |
| K223766 | NUVISION™ NAV Ultrasound Catheter | Biosense Webster Inc | OBJ | Class II | |
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | Biosense Webster Inc | DQK | Class II | |
| K223524 | IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 | Morlaser Shenzhen Co., Ltd. | OHT | Class II | |
| K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | bioMerieux, Inc. | LON | Class II | |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd | EBG | Class II | |
| K223327 | Sterile Aesthetic Cannula and Hypodermic Needle | Shanghai Kindly Enterprise Development Group Co., Ltd. | FMI | Class II | |
| K223056 | JAWS Nitinol Staple System | Paragon 28 | JDR | Class II | |
| K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K222755 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | LNH | Class II | |
| K222622 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | KPE | Class II | |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | BIOTRONIK AG | LIT | Class II | |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | FBN | Class II | |
| K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | IOR | Class I | |
| K213844 | Surgical Gown | Bayteks Teknik Tekstil San. ve Tic. A.S. | FYA | Class II | |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | Stryker Corp. | HAW | Class II | |
| K230175 | Digital Radiography CXDI-CS01 | Canon, Inc. | MQB | Class II | |
| K230131 | ReShape Calibration Tubes | Reshape Lifesciences | KNT | Class II | |
| K223891 | Cobra Catheter System | Endovascular Engineering, Inc. | QEW | Class II | |
| K223815 | ONE DROP Lancing Device | Stat Medical Devices, Inc. | QRK | Class II | |
| K223407 | Versana Essential | GE Healthcare | IYN | Class II | |
| K223046 | Xpert® FII & FV | Cepheid | NPR | Class II | |
| K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology Inc. | LOX | Class II | |
| K222869 | Arm Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K222389 | ZEUS System | iRhythm Technologies, Inc. | DQK | Class II | |
| K222271 | Verisafe Safety sterile needles | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K221874 | Altis Single Incision Sling System | MEDLINE INDUSTRIES, LP - Northfield | PAH | Class II | |
| K221523 | Tanning Lamp | Unilam Co., Ltd. | LEJ | Class II | |
| K213669 | Lightscalpel Ls-4020 | Lightscalpel Inc | GEX | Class II | |
| K223225 | 8ch T/R Knee Coil | Shenzhen RF Tech Co., Ltd. | MOS | Class II | |
| K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | MAX | Class II | |
| K221672 | Creo Electrosurgical System with NP1 Instrument | Creo Medical Ltd | NEY | Class II | |
| K221527 | StitchKit | ORIGAMI SURGICAL Inc. | GAM | Class II | |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer | Howmedica Osteonics Corp | ODP | Class II |