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 |
|---|---|---|---|---|---|
| K965077 | Single Toot Abutment System (Sta or St Abutment ) for Single Ooth Cement Retained Restorations | ZimVie US Corp LLC | DZE | Class II | |
| K965028 | Acumed Suture Washer | Acu Med, Inc. | HTN | Class II | |
| K964987 | Datascope Percor Stat - Dl 9.5 Fr. 25 and 40Cc Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0 | Datascope Corp. | DSP | Class II | |
| K964932 | Elevating and Removable Leg and Removable Arm Wheelchair | L & M Resource Information Service, Inc. | IOR | Class I | |
| K964416 | Synthes (U.s.a.)universal Spinal Parellel Connector the Universal Spinal Rod and Screw Fixation System | Synthes (USA) Products LLC | KWQ | Class II | |
| K964128 | Mcl 29 Dermablate Erbium Laser System | Aesculap-Meditec GmbH | GEX | Class II | |
| K964029 | Emergency Relief Kit System | Baxter Healthcare Corporation | LRR | Not classified | |
| K963315 | Vingmed Sound Color Flow Mapping System. System Five | Vingmed Sound, Inc. | IYO | Class II | |
| K962433 | Meadox Exxcel Eptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | DSY | Class II | |
| K961380 | Cpc Probe | Carl Zeiss, Inc. | GEX | Class II | |
| K961021 | Kirschner Knee Modified | Zimmer GmbH | JWH | Class II | |
| K955663 | Abc in-Line Blood Sampling Kit | Utah Medical Products, Inc | CBT | Class I | |
| K970825 | Blue Chip Germicidal Cleaner & Deodorant | S.C. Johnson Professional | LRJ | Class I | |
| K970807 | Mobile Operating Table 1132.01 | Stierlen-Maquet AG | GDC | Class I | |
| K970114 | Ultracal Xs | Ultradent Products Inc. | EJK | Class II | |
| K970042 | Ooli-U(tongue Scraper) | Telefax Intl. | LCN | Class I | |
| K965046 | Isola Twister Connector | Acromed Corp. | MNH | Class II | |
| K965020 | Porous Media Dbf23 Reusable Respiratory Filter | Pentair Filtration Solutions | CAH | Class II | |
| K965017 | Regional Anesthesia Trays | Smiths Industries Medical Systems, Inc. | CAZ | Class II | |
| K965015 | Topaz 30 Surgical Laser System | Esc Medical Systems, Ltd. | GEX | Class II | |
| K964117 | Non-PVC Fluid Path Port Access Infusion Set with Slit Septum Injection Site | Kawasumi Laboratories Co., Ltd. | LJT | Class II | |
| K950017 | Flexiflo Flocator Small Bowel Feeding System | Ross Products | KNT | Class II | |
| K970704 | Personal Catheter | Rochester Medical Corp. | GBM | Class II | |
| K970097 | Proximal Femoral Nail (Pfn) System | Synthes (USA) Products LLC | JDW | Class II | |
| K970084 | Link Cerclage Wire System | Turnkey Intergration USA, Inc. | JDQ | Class II | |
| K970013 | Biorigid Nail Tibia | Aap GmbH and Co. Betriebs KG | HTY | Class II | |
| K965175 | Howmedica Mainstay Anchor | Howmedica Corp. | JDR | Class II | |
| K965164 | Howmedica Modular Replacement System-Proximal Femur | Howmedica Corp. | LPH | Class II | |
| K965145 | Depuy Motech Moss Miami Spinal System | Depuy, Inc. | KWP | Class II | |
| K964882 | Implex Replacement Acetabular Cup Insert | Implex Corp. | LPH | Class II | |
| K964375 | Sysmex Se/ram-1 | Sysmex Corporation | GKL | Class II | |
| K963174 | Holter Digicorder with Pacer Option (Model 483) | Del Mar Avionics | DSH | Class II | |
| K962791 | New Star Model 130 6-Watt Nd: Yag Laser System | New Star Lasers, Inc. | GEX | Class II | |
| K962723 | Trace Hdl Cholesterol - Automated (Homogen | Trace America, Inc. | LBR | Class I | |
| K962109 | Sls Chromos 694 Qd Ruby Laser to Be Renamed Mehl Qd Ruby Laser System for Hair Removal | Classy Lady by Mehl of Puerto Rico, Inc. | GEX | Class II | |
| K961986 | Manan D Bag | Argon Medical Devices, Inc | EXF | Class II | |
| K961360 | True/fit Femoral Intramedullary Rod System | Encore Orthopedics, Inc. | HSB | Class II | |
| K961343 | Medvision Personal Monitor | Medvision, Inc. | GCJ | Class II | |
| K970598 | Integrated Visualization System | Urohealth, Inc. | FCW | Class II | |
| K970037 | Targogrid | Daum GmbH | LNH | Class II | |
| K965254 | Widex Model Senso Digital (C9) | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K965182 | Rfg-3Cf | Radionics, Inc. | GXD | Class II | |
| K965161 | Smiic (Sectra Medical Image Input Controller) | Sectra-Imtec AB | LMD | Class I | |
| K965051 | Heartport Needle Trocar | Heartport, Inc. | DRC | Class II | |
| K961835 | Protime Microcoagulation System | Accriva Diagnostics, Inc. | GJS | Class II | |
| K961144 | Ms-2000 | Touritu Engineering Co., Inc. | DXN | Class II | |
| K955179 | Contrast Media Set | B.Braun Medical, Inc. | IZI | Class II | |
| K970560 | Uric Acid (Liquid) Reagent Set | Horiba Instruments Incorporated | KNK | Class I | |
| K970430 | Adaptive Compression - Class D/ Class D Agci | Midwest City Hearing Aid Center | ESD | Class I | |
| K970427 | Ksea Uretero-Reno-Fiberscope and Nephro-Fiberscope | Karl Storz Endoscopy-America, Inc. | FGB | Class II |