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 |
|---|---|---|---|---|---|
| K213097 | Armory Motion | Pain Management Technologies | ILO | Class II | |
| K212024 | PAL System | MicroAire Surgical Instruments, LLC | QPB | Class II | |
| K210582 | EasyClip® and EasyClip® Xpress | Stryker Corp. | JDR | Class II | |
| K203757 | Elecsys AMH | Roche Diagnostics GmbH | PQO | Class II | |
| K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co.,Ltd. | FMK | Class II | |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection | Contego Medical, Inc | LIT | Class II | |
| K221077 | Auryon Atherectomy System | Eximo Medical Ltd | MCW | Class II | |
| K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | FGE | Class II | |
| K220988 | EksoNR | Ekso Bionics | PHL | Class II | |
| K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K220729 | The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | OLP | Class II | |
| K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | PBF | Class II | |
| K220259 | ALLY Adaptive Cataract Treatment System | LENSAR, Inc | OOE | Class II | |
| K213587 | MyCRO Band | Otto Bock Healthcare LP | MVA | Class II | |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair LGL | PIF | Class II | |
| K212663 | Helios IV 785 | Laseroptek | GEX | Class II | |
| K211981 | KHEIRON® Spinal Fixation System | S.M.A.I.O | NKB | Class II | |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | KNS | Class II | |
| K211000 | Acutron | Ilooda Co,., Ltd. | GEI | Class II | |
| K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button | Medacta International SA | MBI | Class II | |
| K221371 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co.,Ltd. | FMK | Class II | |
| K213882 | EarliPoint System | Earlitec Diagnostics | QPF | Class II | |
| K213862 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co.,Ltd. | IYN | Class II | |
| K213717 | AIR Recon DL | GE Medical Systems,Llc (GE Healthcare) | LNH | Class II | |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | MEDLINE INDUSTRIES, LP - Northfield | FAD | Class II | |
| K213173 | TrabEx Pro | Microsurgical Technologies, Inc. | MRH | Class II | |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | MBF | Class II | |
| K221438 | WHILL Model F | Whill, Inc. | ITI | Class II | |
| K221335 | D²RS and D²RS 9090 | Stephanix | OWB | Class II | |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | PQA | Class II | |
| K220693 | Zoupure Nitrile Powder Free Examination glove | Thai Rayong Product Glove Zoupure Co., Ltd. | LZA | Class I | |
| K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | KNT | Class II | |
| K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | PHX | Class II | |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | ITX | Class II | |
| K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, Inc. | KLE | Class II | |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | MSX | Class II | |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | KTT | Class II | |
| K221231 | Drug Relief v1 | Dyansys, Inc. | PZR | Class II | |
| K221222 | Surgical Face Mask (HNFM0304) | Shanghai Hua en Industrial Co Ltd | FXX | Class II | |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex GmbH | HTN | Class II | |
| K220612 | PrimeLOC Attachment System | Innovative Product Brands, Inc. | NHA | Class II | |
| K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Healthcare | IYN | Class II | |
| K213448 | Powder Free Nitrile Gloves | St Future International Limited | LZA | Class I | |
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | FHN | Class II | |
| K213222 | Disposable Polypectomy Snare | Beijing Zksk Technology Co., Ltd. | FDI | Class II | |
| K212450 | Keos Anterior Cervical Interbody Fusion Device System | Keos | ODP | Class II | |
| K211207 | Diacare 7000 | Globus Sport and Health Technologies LLC. | PBX | Class II | |
| K213846 | Q2 Blood Administration Sets | Quest Medical, Inc | FPA | Class II | |
| K221314 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K221061 | 21Hq613d | LG Electronics.Inc | PGY | Class II |