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 |
|---|---|---|---|---|---|
| K182407 | Exceed Microneedling device | Mt. Derm GmbH | QAI | Class II | |
| K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) | Waldemar Link GmbH & Co. KG | JWH | Class II | |
| K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | NFJ | Class II | |
| K191598 | AOS ES Retrograde Femoral Nail | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | |
| K191370 | DreaMed Advisor Pro | Dreamed Diabetes Ltd | QCC | Class II | |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | Orthocon, Inc. | MTJ | Unclassified | |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | Acist Medical Systems, Inc. | DXT | Class II | |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | Wilson-Cook Medical Inc. | FDI | Class II | |
| K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System | Medos International SARL | NKG | Class II | |
| K190680 | Favo S-Tlif | Silony Medical GmbH | MAX | Class II | |
| K190492 | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | FFL | Class II | |
| K190427 | Immucise | Terumo Corp. | FMF | Class II | |
| K190343 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, LLC | FRO | Unclassified | |
| K183532 | Latitud Hip Replacement System | Meril Healthcare Pvt. Ltd. | LZO | Class II | |
| K183121 | Qraypen | Aiobio Co., Ltd. | EIA | Class I | |
| K182908 | Ziacom Dental Implant Systems | Ziacom Medical, S.L. | DZE | Class II | |
| K182794 | BionicGym Powered Muscle Stimulator | Medical Currents Ltd | NGX | Class II | |
| K181170 | Trilogy Evo Universal | Respironics, Inc. | CBK | Class II | |
| K181166 | Trilogy Evo | Respironics, Inc. | CBK | Class II | |
| K191711 | ORTHOLOC™ SPS Shoulder Plating System | TORNIER Inc. | HRS | Class II | |
| K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control | Siemens Healthcare Diagnostics Inc. | QFO | Class II | |
| K191345 | Pegasus System | A.M. Surgical, Inc. | HRX | Class II | |
| K191167 | Fungitell STAT | Associates of Cape Cod, Inc. | NQZ | Class II | |
| K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co.,Ltd. | PKT | Class II | |
| K191053 | Xtreme-Loop | Xiros Ltd | MBI | Class II | |
| K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | LRK | Class II | |
| K182820 | The POD | Advanced Facialdontics, LLC | MQC | Unclassified | |
| K191616 | Orthophos S | Dentsply Sirona Inc | OAS | Class II | |
| K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | DQO | Class II | |
| K191325 | EMPOWR Partial Knee | Encore Medical, LP | HSX | Class II | |
| K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners | Davol Inc., Subsidiary of C.R. Bard | GDW | Class II | |
| K190575 | iBreastExam | UE Lifesciences Inc. | NKA | Class II | |
| K190163 | ALARA Neuro Access Kit | Surgentec LLC | PDQ | Class II | |
| K190150 | Sage 2-in-1 Personal Lubricant and Moisturizer | Fairhaven Health | NUC | Class II | |
| K183663 | Microlife Digital Infrared Ear Thermometer | Microlife Intellectual Property GmbH | FLL | Class II | |
| K183572 | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L | FUJIFILM Corporation | FDS | Class II | |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | Cook Incorporated | LJE | Unclassified | |
| K180992 | Biotex | Purgo Biologics Inc. | NBY | Class II | |
| K191635 | Optilite IgM Kit | The Binding Site Group Ltd. | CFN | Class II | |
| K191372 | Lyra | Interacoustics a/S | EWO | Class II | |
| K190749 | 087 Balloon Guide Catheter System | Q'Apel | DQY | Class II | |
| K190123 | MicroPort CoCr Femoral Heads | Microport Orthopedics Inc. | LPH | Class II | |
| K182814 | Rael Tampon | Rael, Inc. | HEB | Class II | |
| K182455 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device, Ltd. | NHA | Class II | |
| K182158 | UNiD Patient-matched PLIF cage | Medicrea International | MAX | Class II | |
| K183325 | Modus Nav | Synaptive Medical Inc | HAW | Class II | |
| K173974 | Drowzle | Resonea, Inc. | MNR | Class II | |
| K191601 | Valleylab FT10 Electrosurgical Platform | Medtronic, Inc. | GEI | Class II | |
| K191585 | iNtuition-Structural Heart Module | Terarecon, Inc. | LLZ | Class II | |
| K191317 | StitchKit | ORIGAMI SURGICAL Inc. | NBY | Class II |