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 |
|---|---|---|---|---|---|
| K080860 | Creaspine Supstance Small Vertebral Body Replacement System | Creaspine | MQP | Class II | |
| K080728 | Ldr Spine Roi-C Implant | Ldr Spine USA | MQP | Class II | |
| K080161 | Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula Anchor | Patton Surgical Corp. | GCJ | Class II | |
| K073295 | Urea/bun, Scal, Nortrol, Abtrol | Thermofisher Scientific Oy | CDQ | Class II | |
| K073006 | Osteotrans -Mx Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | GWO | Class II | |
| K072290 | Pegaso V, Negavent Respirator, Model: Da-3 Plus | Dima Italia SRL | BYT | Class II | |
| K081347 | Iluma Vision | Imtec Corp. | LLZ | Class II | |
| K081274 | Sureskin Silver Bandages | Euromed, Inc. | FRO | Unclassified | |
| K081220 | Modification to Angiosculpt Pta Scoring Balloon Catheter | Spectranetics Corp. | PNO | Class II | |
| K081203 | Ob Tracevue Obstetrical Information Management System with Release F.00 | Philips Medizin Systeme Boeblingen GmbH | HGM | Class II | |
| K081201 | Wbr Xpress3.cardiac | Ultraspect, Ltd. | KPS | Class II | |
| K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | NKB | Class II | |
| K081170 | Prostate Tissue Marker | Senorx, Inc. | NEU | Class II | |
| K081050 | Parietex Progrip Mesh | Sofradim Production | FTL | Class II | |
| K081045 | Destination Renal Guiding Sheath | Terumo Medical Corp. | DYB | Class II | |
| K080934 | Vienna Ring Ct/mr Applicator Set, Round Point Titanium Needle Set, Trocar Point Titanium Needle Set | Nucletron BV | JAQ | Class II | |
| K080551 | University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve Device | University of Utah Hospitals and Clinics | JOW | Class II | |
| K080424 | Hygia Health Services Reprocessed Lncs Sensors, Models Hhs-1858, Hhs-1862, Hhs-1860 and Hhs-1861 | Hygia Health Services, Inc. | NLF | Class II | |
| K073326 | Nrg Transseptal Needle | Baylis Medical Co., Inc. | DXF | Class II | |
| K073244 | Verify Self-Contained Biological Indicator for Vh202 Gaseous Sterilization Processes | STERIS Corporation | FRC | Class II | |
| K073213 | Therabond Antimicrobial Barrier Systems | Choice Therapeutics | FRO | Unclassified | |
| K081320 | Dc-3, Dc-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K081256 | Wireless Body Temperature Monitor, Models Btm-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | FLL | Class II | |
| K081186 | Concave Rn Healing Cap | Straumann USA, LLC | NHA | Class II | |
| K081169 | Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar | Covidien Lp, Formerly Registered AS United States | GCJ | Class II | |
| K081154 | Ultrasound Scanner Flex Focus, Model 1202 | BK Medical ApS | IYO | Class II | |
| K081103 | Loci Thyroid Calibrator with Model Rc610 | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K081074 | Dimension Tshl Flex Reagent Cartridge and Tsh Sample Diluent with Models RF 612 and Kd691 | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K080937 | Powder Free Nitrile Examination Glove, Orange | Gx Corporation Sdn Bhd | LZA | Class I | |
| K080869 | Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg Qc | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K080842 | Apex Knee System, Model Kc-230Xy, Kc-240Xy [ No Holes, 2 Holes] | Omni Life Science, Inc. | MBH | Class II | |
| K080631 | Cleanse.freshen.go; Aligner Cleansing Towelette and Dental Appliance Cleanser | Oral Health Technologies, LLC | EFT | Class I | |
| K080618 | Direct Hba1c, Fructosamine, Glucose Oxidase Liquid | JAS Diagnostics/Drew Scientific | LCP | Class II | |
| K080547 | Orthopilot Next Generation, Model Fs101-Fs106 | Aesculap Implant System, Inc. | HAW | Class II | |
| K080522 | Synthes 3.5 Mm Lcp Distal Tibia T Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K080427 | Watch-Pat Model 100S-2 | Itamar Medical | MNR | Class II | |
| K080321 | Snap Model 7 Snoring and Apnea Recording and Analysis System | Snap Laboratories, LLC | MNR | Class II | |
| K080255 | Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter | Nonin Medical, Inc | DQA | Class II | |
| K080020 | Arcofix | Synthes Spine Co.Lp | KWQ | Class II | |
| K073612 | Uric Acid (Aox), Scal, Nortrol, Abtrol | Thermofisher Scientific Oy | JIX | Class II | |
| K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | HAW | Class II | |
| K073415 | Nemus System; Nemus Pc Peripheral | EB Neuro S.p.A. | IKN | Class II | |
| K073362 | Mropen | Paramed S.r.l. | LNH | Class II | |
| K073261 | Var Monitor | Vortran Medical Technology 1, Inc | BTL | Class II | |
| K072863 | Atramat Pgc25 Poly(glycolide-Co-Epsilon-Caprolactone) Surgical Sutures | Internacional Farmaceutica, S.A. de C.V. | GAM | Class II | |
| K072859 | Atramat Pgla90 Poly(glycolide-Co-L-Lactide) Surgical Sutures | Internacional Farmaceutica, S.A. de C.V. | GAM | Class II | |
| K072564 | Alma Lasers Harmony Xl Multi-Application Platform | Alma Lasers Ltd. | GEX | Class II | |
| K072399 | Del Sol Red Light Therapy System | Edge Systems Corp. | ILY | Class II | |
| K071977 | Tarry Medical Temperature Probes | Tarry Medical Products, Inc. | FMZ | Class II | |
| K081291 | Pre-Cemented Orthodontic Bracket System Extension | Dentsply Interntional | DYH | Class II |