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 |
|---|---|---|---|---|---|
| K992787 | Epicon (Carbosilfocon a) Rigid Gas Permeable Contact Lens Daily Wear | Specialty Ultravision, Inc. | HQD | Class II | |
| K992322 | Snap Model 5 | Snap Laboratories, LLC | MNR | Class II | |
| K991393 | Hyaluronidase, 80 U/ml | Sage Biopharma | MQL | Class II | |
| K991379 | Quinn's Sperm Washing Medium | Advanced Reproductive Technologies | MQL | Class II | |
| K994346 | Abl 77 Ph, Blood Gas and Electrolyte Analysis System | Sendx Medical, Inc. | CHL | Class II | |
| K994148 | 3I Model(s)7426 and 7427 Celsep Centrifuge System | ZimVie US Corp LLC | JQC | Class I | |
| K994046 | Hardydisk Cefaclor 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | Sekisui Diagnostics P.E.I. Inc. | JIR | Class I | |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029ul/9g129ul | Syva Co. | JXN | Class II | |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309ul/9k409ul | Syva Co. | DML | Class II | |
| K993911 | Ceralas D Diode Laser System, Model D15, D25,d50 | Ceram Optec, Inc. | GEX | Class II | |
| K993910 | Tac' Pin | New Deal, S.A. | JDW | Class II | |
| K993904 | Intrastent Doublestrut Ld | Intratherapeutics, Inc. | FGE | Class II | |
| K993878 | Je 2000 | Jack'S Electrodes | IKN | Class II | |
| K993828 | Ceralas D10 810Nm Diode Laser | Ceram Optec, Inc. | GEX | Class II | |
| K993724 | Hsv-2 Elisa Igg, Model El0920g | Mrl Diagnostics | MYF | Class II | |
| K993553 | Gti-Fviii Inhibitor Assay | Immucor GTI Diagnostics, Inc. | GGP | Class II | |
| K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K993085 | Autostat II Anti-Cardiolipin Screen Elisa | Cogent Diagnotics, Ltd. | MID | Class II | |
| K992708 | Iontopatch | Birch Point Medical, Inc. | EGJ | Class II | |
| K000044 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spinewands | ArthroCare Corporation | GEI | Class II | |
| K994354 | Polymer Coated, Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | Flexitech Sdn. Bhd. | LYY | Class I | |
| K994246 | Omni Grace Nitrile, Blue, Examination Glove, Powder-Free, Polymer Coated | Omnigrace, Ltd. | LZA | Class I | |
| K994224 | Prime-Dent Chemical Cure Composite Restorative Material | Prime Dental Manufacturing, Inc. | EBF | Class II | |
| K994042 | Sharp 9000 Phased Array Brain Coil | GE Healthcare Coils | MOS | Class II | |
| K993908 | Nanma Ajustable Constriction Ring | Nanma Mfg Co., Ltd. | LKY | Class II | |
| K993906 | Nanma Non-Adjustable Constriction Ring | Nanma Mfg Co., Ltd. | LKY | Class II | |
| K993857 | The Original Perry, Style 42 White Latex Powdered Surgical Gloves with Protein Content Labeling Claim (60 Micrograms or | Ansell Perry | KGO | Class I | |
| K993840 | Bard Uroforce Balloon Dilation Catheter | C.R. Bard Inc | EZN | Class II | |
| K992648 | Rotary Master | J. Morita USA, Inc. | EBW | Class I | |
| K990530 | Kerlix Md Antimicrobial Gauze Dressing | Kendall | NAD | Class I | |
| K990227 | Ultrashaper Keratome | Lasersight Technologies, Inc. | HNO | Class I | |
| K000048 | Sealouette Fibrin Sealant Extended Droplet Applicator, Model Te-1 | Biosurgical Corp. | FMF | Class II | |
| K994248 | Sensi-Pro, Disposable Pre-Powdered Synthetic Vinyl Patient Examination Gloves with Beige Pigment Additives | Shinemound Enterprise, Inc. | LYZ | Class I | |
| K994193 | Impregum Penta Duosoft | Espe Dental AG | ELW | Class II | |
| K994192 | Impregum Penta M Monosoft | Espe Dental AG | ELW | Class II | |
| K994115 | Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | JMO | Class I | |
| K994085 | Immulite Turbo Hcg, Models Lskcg1, Lskcg5 | Siemens Healthcare Diagnostics Inc. | DHA | Class II | |
| K994082 | Powdered Latex Examination Gloves (Protein Label Claim) (50 Microgram or Less) | Besglove Medicare Sdn. Bhd. | LYY | Class I | |
| K994064 | Blue Nitrile Examination Gloves - Powder Free | Glove Source, Inc. | LZA | Class I | |
| K993900 | Coagulation Electrode, Model 2000; Radiofrequency Generator, Model 20-115 | Broncus Technologies, Inc. | EOQ | Class II | |
| K993713 | Rim-Fix, Acetabular Cup | Surgical Implants, Inc. | JDI | Class II | |
| K993667 | Sulzer Vascutek Sealptfe Vascular Prosthesis | Sulzermedica | DSY | Class II | |
| K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) | Nobel Biocare Uas, Inc. | DZE | Class II | |
| K992957 | Advanced D-Dimer | Siemens Healthcare Diagnostics Inc. | DAP | Class II | |
| K992604 | Henry Schein Surgical Mask | Mitsui Textile Corp. | FXX | Class II | |
| K992273 | Hp Viridia Multi-Measurement Server/compact Portable Patient Monitor M3000a/m3046a/m3016a,rel B | Hewlett-Packard Co. | MHX | Class II | |
| K991162 | Biolox Alumina Ceramic Femoral Head | Smith & Nephew, Inc. | LZO | Class II | |
| K990340 | Arthrex Pla Tissuetak, Model # Ar-1940 Bu | Arthrex GmbH | MAI | Class II |