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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K081664 | Nomad Pro X-Ray System | KaVo Dental Technologies, LLC | EHD | Class II | |
| K081624 | Infx-8000F (Infinix Csi and Infinix Dpi) | Toshiba America Medical Systems, In.C | MQB | Class II | |
| K081621 | Infx-8000C (Infinix Cc-I and Vc-I) | Toshiba America Medical Systems, In.C | JAA | Class II | |
| K081453 | Biograph Hd Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K081144 | Clever Chek Auto-Code Voice Blood Glucose Monitoring System, Model Td-4243 | Taidoc Technology Corporation | NBW | Class II | |
| K080516 | Lamin Air | Remgenic, LLC | BZD | Class II | |
| K073577 | Sharps Transport Tube, Model 50035 | Sharps Compliance, Inc. | MMK | Class II | |
| K073280 | Beneview T Series Patient Monitors, Models T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K063261 | Nuclisens Easyq Enterovirus System | bioMerieux, Inc. | OAI | Class II | |
| K081628 | Modification to Cooltouch, Models Lc225 and Coollipo | New Star Lasers, Inc. | GEX | Class II | |
| K081585 | Endoscopy Video Camera System | Vision Systems Group, A Division of Viking Systems | FET | Class II | |
| K081578 | Accela System | Genesis Biosystems Inc. | GEX | Class II | |
| K081484 | Horizon Xvu | Mennen Medical, Inc. | DQK | Class II | |
| K081428 | Modification to Doubleplay Suture Anchor | Biocomposites, Ltd. | HWC | Class II | |
| K081094 | Olympic Pasteurmatic, Models 3000 and 3500 | Olympic Medical Corp. | MEC | Class II | |
| K081076 | Velocityais, Velocity Ai, Velocityvx, Velocityrt, V-Response | Varian Medical Systems, Inc. | LLZ | Class II | |
| K080811 | Tina-Quant Cystatin C, Calibrator F.a.s. Cystatin C and Cystatin C Andcystatin C Control Set | Roche Diagnostics GmbH | NDY | Class II | |
| K080765 | Crosser Lp System | Flowcardia, Inc. | DQX | Class II | |
| K080692 | Macs CPAP System | Airon Corporation | BTL | Class II | |
| K080687 | Smartburs | SS White Burs LLC | EJL | Class I | |
| K080675 | Pajunk Infiltralong Wound Infiltration Catheter Kit | Pajunk GmbH Medizintechnologie | BSO | Class II | |
| K080652 | Mercury Vco2 Module with Capnostat 5 | Respironics Novametrix, LLC. | BZK | Class II | |
| K080614 | Dr Vision Neo, Dr Vision Dou | Almana Medical Imaging | KPR | Class II | |
| K080368 | Mako Surgical Corp. Unicondylar Knee Implant System II | Mako Surgical Corp. | HSX | Class II | |
| K080304 | Pro TENS, Model Wl-240 Rx | Well-Life Healthcare Limited | GZJ | Class II | |
| K080251 | Apexpro Telemetry Systems | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | GEX | Class II | |
| K080112 | Patient Cable | Med-Dyne | DSA | Class II | |
| K073330 | Freedom Sciences Motion Control Module (Mcm) | Freedom Sciences, LLC | ITI | Class II | |
| K073316 | Cerament Bone Void Filler, Model A0210 | Bonesupport Inc | MQV | Class II | |
| K072985 | Duckworth & Kent Ltd Injector, Model: Dk7797-2 | Duckworth & Kent, Ltd. | KYB | Class I | |
| K071973 | Epley Omniax | Vesticon | LXV | Unclassified | |
| K081590 | Ya Horng Arm Type Digital Blood Pressure Monitor, Models Bp-600, Bp-600R, Bp-600U, Bp-600B, Bp-600Rb, Bp-600Ub, Bp-600J | Ya Horng Electronic Co., Ltd. | DXN | Class II | |
| K081584 | Derma Sciences OTC Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | FRO | Unclassified | |
| K081580 | Beamer Argon Snare Probe | ConMed Corporation | GEI | Class II | |
| K081538 | Tutopatch, Tutomesh | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | FTM | Class II | |
| K081491 | Smith & Nephew Cds System | Smith & Nephew, Inc. | JAA | Class II | |
| K081327 | Relimesh | Herniamesh SRL | FTL | Class II | |
| K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console | Levitronix, LLC | DWA | Class II | |
| K081183 | Woundstat | Traumacure, Inc. | QSY | Unclassified | |
| K080940 | Estelite Sigma Quick | Tokuyama Dental Corporation | EBF | Class II | |
| K080536 | Micro-Touch Nitrafree | Ansell Healthcare Products LLC | LZA | Class I | |
| K073634 | Multigent Creatinine (Enzymatic) Assay | Sentinel CH SpA | JFY | Class II | |
| K072876 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | FRO | Unclassified | |
| K072169 | Durex Synthetic Polyisoprene Male Condom | Ssl Americas, Inc. | MOL | Class II | |
| K081477 | Luxtec Mlx Light Source | Integra Luxtec, Inc. | FCW | Class II | |
| K081392 | Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin | Bioretec Ltd. | HWC | Class II | |
| K081340 | Pediatric Body and Cardiac Coil, Model 01000140201 | Shanghai Chenguang Medical Technologies Co, Ltd | MOS | Class II | |
| K081322 | Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine Coil | Shanghai Chenguang Medical Technologies Co, Ltd | MOS | Class II | |
| K081198 | Echelon Rapid Head Coil, Model Mr-Rhc-150N, Echelon Rapid Torso Coil, Model Mr-Rbc-150N | FUJIFILM Healthcare Americas Corporation | MOS | Class II |