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 |
|---|---|---|---|---|---|
| K961491 | Elecsys Tsh Assay | Boehringer Mannheim Corp. | JLW | Class II | |
| K961470 | Port-a-Pole | Prins Medical Ind., Inc. | FOX | Class I | |
| K961278 | Coulter Stks Analyzer with Cd4 & Cd8 Lymphocyte Analysis | Coulter Corp. | GKZ | Class II | |
| K960726 | Evenflo Soft-Touch Ultra Battery Operated Breast Pump | Evenflo Company, Inc. | HGX | Class II | |
| K955451 | Cvm Transport | Hardy Diagnostics | JSM | Class I | |
| K955361 | Incstar Cytomegalovirus Igg Elisa Assay | Incstar Corp. | LFZ | Class II | |
| K955360 | Incstar Cytomegalovirus Igg Fast Elisa Assay | Incstar Corp. | LFZ | Class II | |
| K954685 | Uritest - Nitrite in Urine Test | Tcpi, Inc. | JMT | Class I | |
| K954468 | Mb/bact Mycrobacteria Detection System | bioMerieux, Inc. | MDB | Class I | |
| K954156 | Stc Diagnostics Auto-Lyte Urinary Leukocyte Esterase Assay | Solarcare Technologies Corp,Inc. | KQO | Class I | |
| K953813 | London Royal Consumer Products Latex Condoms | London International U.S. Holdings, Inc. | LTZ | Class II | |
| K962321 | Arthocare Arthroscopic Electrosurgery System Model 970 | ArthroCare Corporation | HRX | Class II | |
| K962070 | Ysi 400 Series Atuoclavable Reusable Temperature Probe | Yellow Springs Instrument Co., Inc. | FLL | Class II | |
| K961959 | Md Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | GAA | Class I | |
| K961880 | Medcare Suction Connecting Tubing | Medcare Medical Group, Inc. | GCX | Class II | |
| K961727 | Natural-Hip System - Calcar Replacement Hip Stem | Intermedics Orthopedics | LZO | Class II | |
| K961652 | Low Profile Plastic Port Detached Catheter System Catalog #1017 | Arrow Intl., Inc. | LJT | Class II | |
| K961615 | Low Profile Titanium Port Detached Catheter System Catalog #1037 | Arrow Intl., Inc. | LJT | Class II | |
| K961264 | Endopath Ez-RF Linear Cutter and Coagulation | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K961182 | 3D Scope | Oktas | GCJ | Class II | |
| K961179 | Sentinel Lipase Liquid Model 17.401B | Equal Diagnostics, Inc. | CHI | Class I | |
| K960522 | Diopexy Probe | Iriderm Div. | HQF | Class II | |
| K962604 | Prosys Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing | Convatec, A Division of E.R. Squibb & Sons | FAQ | Class I | |
| K962365 | Xenon Lightsource | Dsp Worldwide | GCT | Class II | |
| K962348 | Prime & Bond 2.1 Multipurpose Dentin/enamel Bonding Agent | Dentsply Intl. | KLE | Class II | |
| K962303 | Sterngold Cf | Sterngold/Implamed | EJT | Class II | |
| K962302 | Pegasus Dental Alloy | Sterngold/Implamed | EJT | Class II | |
| K962301 | Sterngold G-Hard Metal Alloy | The Stern Metals Co., Inc. | EJS | Class II | |
| K962123 | Akrotech 4000T Kinetic Turning Low Air Loss System | Lumex, Inc. | FNM | Class II | |
| K962065 | 3M Vitrebond Light Cure Glass Ionomer/base | 3M Company | EMA | Class II | |
| K962003 | Tuat Splatter Control Shield Scs-300 | Taut, Inc. | KKX | Class II | |
| K961933 | Circle Nephrostomy Catheter Set | Cook Incorporated | LJE | Unclassified | |
| K961856 | Auto Suture Chemosite Tunneler | United States Surgical, A Division of Tyco Healthc | LJS | Class II | |
| K961736 | 17 Angulated Abutment | Nobelpharma USA, Inc. | NHA | Class II | |
| K961720 | Ceramco Crowns and Bridges | Eric S. Small, Dds | EJH | Class II | |
| K961717 | Nmi Retrograde Cardioplegia Cannula-Rccs | Naltiac Medical, Inc. | DWF | Class II | |
| K961626 | Solo CPAP System | Respironics, Inc. | BZD | Class II | |
| K961611 | Olympus Basket Graspers (Urology) | OLYMPUS Corporation of the Americas | OCZ | Class II | |
| K961583 | A Port Detached Catheter System Catalog #1002 | Arrow Intl., Inc. | LJT | Class II | |
| K961512 | Perkins Hand-Held Applanation Tonometer | Clement Clarke, Inc. | HKY | Class II | |
| K961505 | Bend-a-Beam Hand Control Malleable Abc Handpiece | Conmedcorp | GEI | Class II | |
| K961502 | Lubricating Jelly, Low Viscosity | Span-America Medical Systems, Inc. | KMJ | Class I | |
| K961457 | Subliminator | Healex Products, Inc. | EJI | Class II | |
| K961336 | Medtronic Vascular Catheter, Multi Lumen Models 84640, 84652 | Medtronic PS Medical | LJS | Class II | |
| K961204 | Mumps Igg Test | Zeus Scientific LLC | LJY | Class I | |
| K960721 | Paceart Wrist Electrodes | Paceart, Inc. | DRX | Class II | |
| K960696 | Permalute Composite Luting/restorative Resin System | Ultradent Products Inc. | KLE | Class II | |
| K955231 | Medfusion Model 2001 Syringe Infusion Pump | Medex, Inc. | FRN | Class II | |
| K953762 | Heart 400 ECG Transmitter | Aerotel Ltd. | DXH | Class II | |
| K962308 | Eub-905 | Hitachi Medical Corp. of America | IYO | Class II |