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 |
|---|---|---|---|---|---|
| K994118 | Osmanthus, Kongfu, and Gobon, Natural Rubber Latex Condoms | Guilin Latex Factory | HIS | Class II | |
| K993806 | Dialguard Endotoxin Removal Device | Clarigen, Inc. | FIP | Class II | |
| K970569 | Bio-Blocks | Geistlich Pharma AG | LYC | Class II | |
| K002321 | Pain Care 2000L | Breg, Inc. | MEB | Class II | |
| K002112 | Rubbercare Polymer-Chlorinated Powder-Free Guardian Polymer-Chlorinated Powder-Free | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | |
| K001967 | Pvp-Polyvinylpyrrolidone Reagent, Model Cat#2210 | Invitrocare Inc | MQL | Class II | |
| K001944 | Hac-300 Head Array Coil | Mri Devices Corp. | MOS | Class II | |
| K001870 | Millennium 9000 Phased Array Neurovascular Coil | GE Healthcare Coils | MOS | Class II | |
| K001810 | Urisite Urine Collection Kit for Microalbumin/creatinine Testing | Flexsite Diagnostics, Inc. | JIR | Class I | |
| K001677 | Baby Dopplex 4000 (Bd4000) | Huntleigh Diagnostics, Ltd. | HGM | Class II | |
| K001604 | Dana Diabecare | Sooil Development Co., Ltd. | LZG | Class II | |
| K001572 | Neolus Needle | Terumo Europe N.V. | FMI | Class II | |
| K000421 | Biogel Neotech II Powder-Free Neoprene Surgeon's Glove | Ssl Americas, Inc. (Regent Medical) | KGO | Class I | |
| K994124 | Niprotect Powder-Free Nitrile Examination Gloves | Mapa Professional | LZA | Class I | |
| K993875 | Bmt Anscore Health Management System | Boston Medical Technologies, Inc. | DPS | Class II | |
| K002217 | Nitrile Exam Glove, Powder-Free, Color White | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | |
| K002216 | Nitrile Examination Glove, Pre-Powdered, Color White | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | |
| K002181 | Gdc Ultrasoft Coil | Boston Scientific Corporation | HCG | Class II | |
| K002114 | Rubbercare Guardian Polymer-Coated Powder-Free Latex Examination Gloves: Contains 100 Micrograms or Less of Total Water | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | |
| K001940 | Micor Anesthesia Conduction Kit | Micor, Inc. | CAZ | Class II | |
| K000796 | Magic Mobility 4 X 4 Wheelchair | Vestil Manufacturing Corp. | ITI | Class II | |
| K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | ODA | Class II | |
| K002364 | Protemp H | Espe Dental AG | EBG | Class II | |
| K002353 | Elecsys Ca 15-3 Calcheck | Roche Diagnostics GmbH | JIS | Class II | |
| K002205 | Carony | Bruno Independent Living Aids, Inc. | IOR | Class I | |
| K002190 | Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp) | Cp Medical | GAM | Class II | |
| K002171 | Invacare Lift Chair | Invacare GmbH | INO | Class II | |
| K002063 | Biotrace, Model 1730 | Bryan Corp. | MYU | Class II | |
| K002006 | Lifeshield Additive Piercing Pin | Abbott Medical | FPA | Class II | |
| K001953 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K001914 | Clearfil Repair | Kuraray Co. | KLE | Class II | |
| K001860 | Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra | FKA Distributing Co., LLC | IMC | Class II | |
| K001815 | Dc Zirkon | Austenal, Inc. | EIH | Class II | |
| K001799 | Dc-Tell | Austenal, Inc. | EBF | Class II | |
| K001655 | Permlastic 2 | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K001609 | Mallard Air Oxygen Accublender | Mallard Medical, Inc. | BZR | Class II | |
| K001565 | Steerable Retrograde Cardioplegia Cannula with and without Duraflo Treatment, Models Srco14mib, Diisrco14mib | Edwards Lifesciences LLC | DWF | Class II | |
| K001523 | Ultima Metal-on-Metal Acetabular Cup | Depuy Orthopaedics Inc. | KWA | Class III | |
| K001498 | The Fugo Blade | Medisurg, Ltd. | NCR | Class II | |
| K001403 | Sigma Diagnostics Infinity Glucose Reagent, Models 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P | Sigma Diagnostics, Inc. | CFR | Class II | |
| K001091 | Cardioset (Hardware), Model Ho4; Cardioset Scl (Software), Model V3.01 | Next Millennium Software Solutions, Inc. | DXH | Class II | |
| K000913 | Powder Free Latex Patient Examination Gloves with Protein Labeling Claim (50 Micrograms or Less) | Handsafe Products Sdn. Bhd. | LYY | Class I | |
| K000114 | Rs-4M+muscle Stimulator | RS Medical | IPF | Class II | |
| K993913 | True | Infinity Extrusion & Engineering, Inc. | LIT | Class II | |
| K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 | Heinz Kurz GmbH Medizintechnik | ETB | Class II | |
| K002118 | Stockert Compact System Version 2.0 | Stoeckert Instrumente | DTQ | Class II | |
| K002116 | S3 Cardioplegia Control Module Version 2.0 | Medical Device Consultants, Inc. | DTQ | Class II | |
| K002015 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | LYZ | Class I | |
| K002012 | Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | LYZ | Class I | |
| K001887 | Modification to Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II |