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 |
|---|---|---|---|---|---|
| K002815 | Gold Core HF Pre Solder | Jeneric/Pentron, Inc. | EJT | Class II | |
| K002738 | Bayer Rapidpoint 400 System | Bayer Corp. | CHL | Class II | |
| K002393 | Non-Spermicidal Lubricated Male Latex Condom | Innolatex Sdn. Bhd | HIS | Class II | |
| K002156 | Appraise Urine Microalbumin Collection Kit | Osborn Group, Inc. | CGX | Class II | |
| K000081 | Manual and Remote Controlled Applicator System | Isotopes and Metals, Ltd. | JAQ | Class II | |
| K993406 | Trax, Powered Wheelchair, Model 308686-00-0 | Permobil, AB | ITI | Class II | |
| K003721 | Modification to Olympus Au2700 Clinical Chemistry Analyzer | OLYMPUS Corporation of the Americas | JJE | Class I | |
| K003622 | M2376a Devicelink System, Model M2376a | Agilent Technologies, Inc. | MWI | Class II | |
| K003158 | Roche Diagnostics Ck-Mb | Roche Diagnostics GmbH | JHW | Class II | |
| K003120 | Modification to Integra Reagent Cassette for Hemoglobin A1c | Roche Diagnostics GmbH | LCP | Class II | |
| K003092 | Modification to Vnus Closure System | Vnus Medical Technologies, Inc. | GEI | Class II | |
| K003000 | Grams Nylon Nonabsorbable Suture | Gramsmed, LLC | GAR | Class II | |
| K002999 | Grams Polypropylene Nonabsorbable Suture | Gramsmed, LLC | GAW | Class II | |
| K002984 | Ehc400 Desktop Patient Station; Ehc600 Care Provider Station | Cybercare Technologies, Inc. | DQD | Class II | |
| K002923 | Dynamic Joint Distractor II External Fixation System | Howmedica Osteonics Corp | LXT | Class II | |
| K002920 | Megavision Cpx, Megavision Fa, Model I and II | Escalon Medical Corp | HKI | Class II | |
| K001927 | Vectra (Tm) Vascular Access Graft-5Mm Diameter,6mm Diameter and Vectra (Tm) Vascular Access Graft for Revision-5Mm Diame | Thoratec Laboratories Corp. | DSY | Class II | |
| K001441 | Saturn Blood Glucose Monitoring Test Strip | Lifescan, Inc. | CGA | Class II | |
| K003797 | Ace Aim Ttc Fusion Nail | Depuy Orthopaedics Inc. | HSB | Class II | |
| K003770 | Bird Tbird Legacy Ventilator | Bird Products Corp. | CBK | Class II | |
| K003711 | Ambulatory Blood Pressure Monitoring System, Model Se-25M/25p | Sein Electronics Co., Ltd. | DXN | Class II | |
| K003656 | X-Posure System Version 2 Mammo | Pronosco A/S | KGI | Class II | |
| K003447 | Protract Press Fit Hip Stem | Globus Medical, Inc. | LPH | Class II | |
| K003439 | Vivant Breast Lesion Localization Device | Vivant Medical, Inc. | KNW | Class II | |
| K003363 | M2a 32Mm Taper System | Zimmer GmbH | KWY | Class II | |
| K003211 | Hoffmann II Dynamization/distraction Rod-to-Rod Coupling | Howmedica Osteonics Corp | LXT | Class II | |
| K003205 | Transfx Angled Rods | Immedica, Inc. | LXT | Class II | |
| K003170 | Rythmic and Rythmic UV | Essilor Intl. | LPL | Class II | |
| K003161 | Esstech Multi Toric Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact Lens for Daily Wear (Clear and Tint | Les Laboratoires Blanchard | LPL | Class II | |
| K003147 | Lyra Series Surgical Laser System (Sl Series, Nd:yag Configuration) | Laserscope | GEX | Class II | |
| K003048 | All Terrain Wheelchair (Atw) | Roll-Ability (Pty), Ltd. | IOR | Class I | |
| K003038 | Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model M1175a/76a/77a,rev.l,m1205a,rev.l,m1034a | Agilent Technologies Deutschland GmbH | OLW | Class II | |
| K003018 | Titan Tibial Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K003015 | Ssc's Pcl Monofilament Sas, Violet, Coated, Model Tbd | Surgical Specialties Corp | GAN | Class II | |
| K003001 | Grams Silk Nonabsorbable Suture | Gramsmed, LLC | GAP | Class II | |
| K002972 | Merogel Control Gel ENT Surgical Dressing | Medtronic Xomed, Inc. | KHJ | Class II | |
| K002971 | Mtg - Minitub Heated Stage Systems | Zander Medical Supplies, Inc. | MQG | Class II | |
| K002906 | Ultracision Harmonic Scalpel System, Models Gen01, Gen02, Gen03, Hp052, Hp053, Hsa07 | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K002747 | Reflection Cross-Linked Uhmwpe Acetabular Components | Smith & Nephew, Inc. | LPH | Class II | |
| K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | KWP | Class II | |
| K002384 | M-Xx Oxygen Sensors | International Business Strategies | CCL | Class II | |
| K001491 | Quickie 2 Power Assist Wheelchair | Sunrise Medical, Inc. | ITI | Class II | |
| K001282 | Aiw Water System for Hemodialysis | American Industrial Water | FIP | Class II | |
| K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | DSM Biomedical, Inc. | MQV | Class II | |
| K993641 | Metalyzer, Model 2; Metalyzer, Model 3 | Cortex Biophysik GmbH | BTY | Class II | |
| K003247 | Creatinine | JAS Diagnostics/Drew Scientific | CGX | Class II | |
| K003228 | K-Defib/pace Multifuction Pediatric Electrode, Model Kdp-70A | Katecho LLC | MKJ | Class III | |
| K003178 | Elecsys Hcg and Beta Test System | Roche Diagnostics GmbH | DHA | Class II | |
| K002989 | Proclude | Ortek Therapeutics, Inc. | EJR | Class I | |
| K002506 | Breathing Filter for Disposable Anesthesia Breathing Circuit | Abbott Medical | CAH | Class II |