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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | Titan Spine, LLC | MAX | Class II | |
| K170224 | Spider Cervical Plating System | Xtant Medical Holdings, Inc. | KWQ | Class II | |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | Bionime Corporation | NBW | Class II | |
| K162609 | ClearPath Aligner | Clearpath Orthodontics | NXC | Class II | |
| K162398 | CO2 Laser Therapy Systems | Beijing Sincoheren Science & Technology Development Co., Ltd | ONG | Class II | |
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) | Villa Sistemi Medicali S.p.A. | MUH | Class II | |
| K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | Sportarredo Group S.C. | LEJ | Class II | |
| K171669 | g.Nautilus PRO | G.tec Medical Engineering GmbH | GWL | Class II | |
| K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | |
| K170549 | Tokuyama Curegrace | Tokuyama Dental Corporation | EBI | Class II | |
| K170239 | Leica FL560 | Leica Microsystems (Schweiz) AG | IZI | Class II | |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Cerenovus, Inc. | DQY | Class II | |
| K171267 | NavLock Trackers | Medtronic Navigation, Inc | OLO | Class II | |
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK | Becton Dickinson & Co | OYE | Class II | |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NLQ | Unclassified | |
| K170871 | DigniCap Scalp Cooling System | Dignitana AB | PMC | Class II | |
| K170844 | Gemini-C Hybrid Cervical Interbody System | Osseus Fusion Systems LLC | ODP | Class II | |
| K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical Ltd | ONB | Class II | |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | AGFA Healthcare Corp. | LLZ | Class II | |
| K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip | Asahi Intecc Co., Ltd. | MOF | Class II | |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | Xiros Ltd | GAT | Class II | |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | Welch Allyn Inc | MHX | Class II | |
| K171612 | ACUITY Pro Lead Delivery System | Boston Scientific Corporation | DQY | Class II | |
| K171586 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | JXG | Class II | |
| K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | |
| K170794 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K170372 | SpiralTech Dental Implant System | Spiraltech Superior Dental Implants, Inc. | DZE | Class II | |
| K170249 | GRAVITY™ Syndesmosis LP | Wrightmedicaltechnologyinc | HTN | Class II | |
| K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 | Toshibamedical Systems Corporation | JAK | Class II | |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | FUJIFILM Healthcare Americas Corporation | MQB | Class II | |
| K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | DSY | Class II | |
| K162640 | iVitri EZ | Reprobitech Corp. | MQK | Class II | |
| K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | EBI | Class II | |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S | Synthes (USA) Products, LLC / Depuy Orthopaedics, Inc. | HRS | Class II | |
| DEN160012 | D2 Dressing | Z-Medica, LLC | POD | Class II | |
| K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens LLC | FRG | Class II | |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | BIOTRONIK AG | MXD | Class II | |
| K170940 | Rickettsia Real-time PCR Assay | Centers for Disease Control and Prevention (CDC) | PVQ | Class II | |
| K170896 | Admira Fusion x-base | Voco GmbH | EBF | Class II | |
| K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | DQX | Class II | |
| K163524 | Vessel Dilator | Fetzer Medical GmbH & Co.KG | DWP | Class II | |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.p.A. | MBF | Class II | |
| K163212 | Parietene DS Composite Mesh | Sofradim Production | FTL | Class II | |
| K163011 | PHA S1 Spinal System | Phamedica, Inc. | NKB | Class II | |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | ARKRAY Factory, Inc. | PDJ | Class II | |
| K161710 | Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion Cervical | Spinal Analytics & Geometrical Impant Co, LLC | MAX | Class II | |
| DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M | Siemens Healthcare Diagnostics Inc. | PWD | Class II | |
| K171239 | TULA Tube Delivery System | Tusker Medical Inc. | ETD | Class II | |
| K170830 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | OVE | Class II | |
| K170213 | SupraSDRM Biodegradable Matrix Wound Dressing | Polymedics Innovations | QSZ | Unclassified |