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 |
|---|---|---|---|---|---|
| K011342 | Coulter Lh 750 Hematology Analyzer, Model 6605632 | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K011117 | Mps Acacia Medflo Infusion (Li) and Mps Acacia Medflo Infusion (Li) Keep Vein Open (Kvo) Elastomeric Pumps | Mps Acacia | MEB | Class II | |
| K011092 | Candela Sptl-1E Pulsed Dye Laser | Candela Corporation | GEX | Class II | |
| K011085 | Guidewire Introducer Safety Needle | Greatbatch Medical | DYB | Class II | |
| K010871 | Tgl Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | CDT | Class I | |
| K010841 | Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device | Acon Laboratories, Inc. | DIO | Class II | |
| K010235 | Tempteller Infrared Ear Thermometer, Model CT-30/ CT-30Dx | Oriental System Technology, Inc. | FLL | Class II | |
| K004026 | Braided Guiding Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K003876 | US Sensor #Cg-930P; Toco Sensor Cg-940P | Card Guard Scientific Survival, Ltd. | HEL | Class II | |
| K003662 | Spine Works Collar | Spine Works | HAX | Class II | |
| K003254 | Cortez Needle Free IV Connector, Model Mmd-001 | Mission Medicl Devices | FPA | Class II | |
| K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | KNT | Class II | |
| K002099 | S38 (Polymacon) Spherical, Aspherical, Toric and Multifocal Soft Contact Lens for Daily Wear(clear and Tinted, Fully- | Bescon Co., Ltd. | LPL | Class II | |
| K001962 | S45 (Ocufilcon a) Spherical, Aspherical, Toric and Multifocal Soft Contact Lens for Daily Wear (Clear and Tinted, Fully- | Bescon Co., Ltd. | LPL | Class II | |
| K011787 | Precision Tuna Office System with No Rectal Temperature Monitoring Tape | Vidamed, Inc. | KNS | Class II | |
| K011243 | Chattanooga Dry Heat Whirlpool, Model 2000 | Chattanooga Group, Inc. | LSB | Class II | |
| K011099 | Global Fx Porous-Coated Humeral Stem | Depuy Orthopaedics Inc. | MBF | Class II | |
| K010503 | Amigo Wheelchair | Amigo Mobility Intl., Inc. | INI | Class II | |
| K011922 | Powdered Latex Examination Gloves | Seltom Pacific Sdn. Bhd. | LYY | Class I | |
| K011731 | Tri-Point Liquimmune Liquid Assayed Control Levels 1,2, and 3 | Medical Analysis Systems, Inc. | JJY | Class I | |
| K011713 | Safeskin Neon Nitrile - Powder Free Neon Exam Glove | Kimberly-Clark Corporation | LZA | Class I | |
| K011492 | In Ten-S | Ivoclar North America, Inc. | EBF | Class II | |
| K011436 | Mobile-Patient Viewer | Data Critical Corp. | DPS | Class II | |
| K011170 | Synthes 2.7 Mm Lc-Dcp, 3.5 Mm Profile | Synthes (USA) Products LLC | HRS | Class II | |
| K011130 | Premium | Kulzer GmbH | ELM | Class II | |
| K010964 | Auto-Drive Lag Screw System | Osteomed | HWC | Class II | |
| K010668 | Bayer Diagnostics Advia Centaur Rubella Igm Assay | Bayer Corp. | LFX | Class II | |
| K003818 | Titanium Abutment Heads for Imz Implants | Titan Implants, Inc. | DZE | Class II | |
| K011797 | Bioztect Sensor and Bioztect Cable | Cardiodynamics International Corp. | DSB | Class II | |
| K011766 | 6F Evaluator Electrophysiology Catheter, Crd # 402720,402722; 6F Eavuator Electrophysisology Catheter, Jsn #402721, 4027 | Abbott Medical | DRF | Class II | |
| K011734 | 6-French, 20-Electrode Electrophysiology Diagnostic Catheter, Models 6U20xxx, 6B20xxx, and 6F20xxx | Mogul Enterprises | DRF | Class II | |
| K011350 | Starband Cranial Orthosis | Orthomerica Products, Inc. | OAN | Class II | |
| K011141 | Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7800Tc | Shimadzu Corp. | JAK | Class II | |
| K011114 | Etymotic Research Er-10D Oae Probe | Etymotic Research, Inc. | EWO | Class II | |
| K011041 | Waterlase, Millennium | Biolase MG LLC | GEX | Class II | |
| K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/s, Smartjet Bone Graft Liquid Applicator (Dual Lumen Cannula | Terumo BCT, Ltd | LYC | Class II | |
| K003855 | Hyalomatrix Co | Fidia Advanced Biopolymers SRL | KHJ | Class II | |
| K003438 | Smart Rad | CMT Medical Technologies, Ltd. | MQB | Class II | |
| K002835 | Bodystat | Bodystat Ltd | MNW | Class II | |
| K002580 | Prairie Cruiser | Raye'S, Inc. | ITI | Class II | |
| K011947 | Emit 2000 Valproic Acid Assay, Model Osr4g229ul | Syva Co. | LEG | Class II | |
| K011920 | Emit 2000 Digoxin Assay, Model Osr4h229 | Syva Co., Dade Behring, Inc. | KXT | Class II | |
| K011824 | Agilent M2636b Telemon B Monitor (Telemon B) | Agilent Technologies, Inc. | DSI | Class II | |
| K011740 | Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000) | Meddev Corp | MML | Class II | |
| K011719 | Plus Cancellous Bone Screws | Plus Orthopedics | HWC | Class II | |
| K011573 | Hyaluronidase in Htf Medium; Hyaluronidase in Ebss Medium | Conception Technologies | MQL | Class II | |
| K011505 | Immulite Intact Pth, Model Lkpp1 (100 Tests), Lkpp5 (500 Tests), Immulite 2000 Intact Pth, Model L2kpp (200 Tests), L2k6 | Siemens Healthcare Diagnostics Inc. | CEW | Class II | |
| K011481 | 10% Pvp; 10% Pvp in Ebss Solution | Conception Technologies | MQL | Class II | |
| K011478 | I-Stat System | I-Stat Corp. | KHP | Class I | |
| K011303 | Randox Phenobarbital | Randox Laboratories, Limited | DLZ | Class II |