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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty Ltd | QSZ | Unclassified | |
| DEN140024 | cNEP Airway | Sommetrics | PMB | Class II | |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | Volcano Corporation | IYO | Class II | |
| K153318 | Philips Eleva Workspot with SkyFlow | Philips Medical Systems DMC GmbH | MQB | Class II | |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Medrad, Inc. | NUH | Class II | |
| K152460 | Rectangular Corpectomy Cage | Spinal Elements, Inc | MQP | Class II | |
| K152370 | PRECICE Trauma Nail System | Ellipse Technologies, Incorporated | HSB | Class II | |
| K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | IZH | Class II | |
| K151168 | Nexodyn AOS Wound Care Solution | Apr Applied Pharma Research S.A. | FRO | Unclassified | |
| K151074 | Magnetic Reasonance Imaging System | Jiangsu Magspin Instrument Co., Ltd | LNH | Class II | |
| K151050 | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | HCC | Class II | |
| K150997 | Ruby Star | Bison Medical Co., Ltd | GEX | Class II | |
| K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | OWN | Class II | |
| K150664 | NeoLas | Sheaumann Laser, Inc. | GEX | Class II | |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M) | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K142125 | New Medax Biopsy Systems | Medax S.r.l. Unipersonale | KNW | Class II | |
| K141157 | Bondease Topical Skin Adhesive | OptMed, Inc | MPN | Class II | |
| K153437 | Apex Revision Knee System | Omni Life Science, Inc. | JWH | Class II | |
| K153408 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K153401 | Gr40cw | Samsung Electronics Co., Ltd. | MQB | Class II | |
| K153378 | Monster BITE Screw System | Paragon 28 | HWC | Class II | |
| K153210 | Defibrillator Analyzer Variable Load | BC Group International Inc | DRL | Class II | |
| K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | LKF | Class II | |
| K153085 | Q Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | IYN | Class II | |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | Inova Diagnostics, Inc. | MSV | Class II | |
| K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient | William A. Cook Australia Pty, Ltd. | MQL | Class II | |
| K152774 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K152755 | FastFrame External Fixation System-Ankle Spanning | Zimmer GmbH | KTT | Class II | |
| K152714 | Quanta Forte | Quanta System Inc. | GEX | Class II | |
| K152692 | Powder Free Vinyl Patient Examination Gloves (Green) | Supermax Plastic Products Co., Ltd. | LYZ | Class I | |
| K152548 | AXI+LINE Proximal Bunion Correction System | Medartis AG | HRS | Class II | |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating System | Osteomed | HRS | Class II | |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Maquet Critical Care AB | CBK | Class II | |
| K151672 | Cerner CareAware Event Management | Cerner Corporation | MSX | Class II | |
| K151481 | Sahara Stabilization System | K2M, Inc | OVD | Class II | |
| K151445 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | FRG | Class II | |
| K151284 | Electric Double Breast Pumps | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | HGX | Class II | |
| K150950 | FreezeKit Cleave , ThawKit Cleave | Vitrolife Sweden AB | MQL | Class II | |
| K150934 | Powder Free Vinyl Patient Examination Glove (Non?-Sterile) | Lpl (Hui Zhou) Glove | LYZ | Class I | |
| K150870 | HydroPearl Microspheres, HydroPearl Microspheres | Terumo Cardiovascular Systems Corporation | KRD | Class II | |
| K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | NBW | Class II | |
| K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension | ConMed Corporation | GEI | Class II | |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience Inc | JIT | Class II | |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K153306 | Imbibe Needle | DSM Biomedical, Inc. | KNW | Class II | |
| K152532 | AERO -C Cervical Cage System | Howmedica Osteonics Corp | ODP | Class II | |
| K152515 | TOMCAT Cervical Spinal System | Choicespine, LP | OVE | Class II | |
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | The Binding Site Group Ltd. | PDE | Class II | |
| K152387 | Fluent Inflation Device | Vascular Solutions LLC | MAV | Class II | |
| K152384 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | DPS | Class II |