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 |
|---|---|---|---|---|---|
| K011290 | Prognost Es, Model 0302 0000 | Xmar Corp. | IZF | Class II | |
| K011252 | Eub-6000 Diagnostic Ultrasound Scanner Sp-711 Sonoprobe System | Hitachi Medical Corp. | IYO | Class II | |
| K011111 | Mxd100/mx 20, or Mx 30, or Mx 40 or Mx 50--(Mxd 100 Series) | Modular X-Ray Devices | KPR | Class II | |
| K011105 | Suturtek Fastclose Fascia Closure Device | Qrc Consulting | GAL | Class II | |
| K011027 | Fortaflex Surgical Sling | Organogenesis, Inc. | FTM | Class II | |
| K011002 | Intuitive Surgical Da Vinci Surgical System, Model Isi 1000 | Intuitive Surgical, Inc. | NAY | Class II | |
| K010946 | Mark 9000 Phased Array Shoulder Coil | GE Healthcare Coils | MOS | Class II | |
| K010811 | Perc-D Spinewand | ArthroCare Corporation | HRX | Class II | |
| K010783 | 2.0/2.4 Cannulated Screw System | Osteomed | HWC | Class II | |
| K010773 | Breast Biopsy Device/magnetom Systems | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K010716 | Val Lux 600 Surgical Light (Plus and Rs), Model Ml600/s: Single Light Head, Ml600/ss: Single Light Head, Ml600/1d): Doub | Valmed SRL | FSY | Class II | |
| K010675 | Ensil Fabric | Gottfried Medical, Inc. | MDA | Class I | |
| K010639 | Convergence Cervical Spinal System | Spinal Innovations, LLC | KWQ | Class II | |
| K003788 | Synthes Resorable Meshes and Sheets | Synthes (USA) Products LLC | HRS | Class II | |
| K003500 | Rebstock Yasargil Aneurysm Clip | Rebstock - Instrumente GmbH | HCH | Class II | |
| K003033 | Scaphix, Staple, Fixation, Bone | Avanta Orthopaedics, Inc. | JDR | Class II | |
| K011374 | Jewel Mps | Vestil Manufacturing Corp. | IOR | Class I | |
| K011369 | Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory) | Safety Syringes, Inc. | MEG | Class II | |
| K011362 | Gold Core 73 Ls | Jeneric/Pentron, Inc. | EJT | Class II | |
| K011304 | Ob-1 Fetal Monitor | Analogic Corp. | HGM | Class II | |
| K011153 | Alante, Battery Operated Power Wheelchair | Golden Technologies, Inc | ITI | Class II | |
| K011143 | Tina-Quant D-Dimer Test System | Roche Diagnostics GmbH | GHH | Class II | |
| K010597 | Synchron Lx Systems High Sensitivity C-Reactive Protien (Crph) Reagent | Siemens Healthcare Diagnostics Inc. | DCK | Class II | |
| K010594 | Dj Orthopedics Post Screw | DJ Orthopedics, LLC | HWC | Class II | |
| K010496 | Cedia Dau Amphetamines/ecstasy Assay | Microgenics Corporation | LAF | Class II | |
| K010279 | Medisystems Luer Access Injection Site | Medisystems Corp. | FPA | Class II | |
| K010125 | Instant-View Barbituate Urine Dip Strip Test | Alfa Scientific Designs, Inc. | DIS | Class II | |
| K010080 | Instant-View Morphine (2000) Urine Cassette Test | Alfa Scientific Designs, Inc. | DOE | Class II | |
| K010079 | Instant-View Morphine (2000) Urine Dip Strip Test | Alfa Scientific Designs, Inc. | DOE | Class II | |
| K010047 | Instant-View Phencyclidine (Pcp) Urine Cassette Test | Alfa Scientific Designs, Inc. | LCM | Unclassified | |
| K010045 | Instant-View Phencyclidine (Pcp) Urine Dip Strip Test | Alfa Scientific Designs, Inc. | LCM | Unclassified | |
| K010015 | Instant-View Methadone Urine Cassette Test | Alfa Scientific Designs, Inc. | DJR | Class II | |
| K010014 | Instant-View Methadone Urine Dip Strip Test | Alfa Scientific Designs, Inc. | DJR | Class II | |
| K003881 | Instant-View Benzodiazepine (Bzd) Urine Cassette Test | Alfa Scientific Designs, Inc. | JXM | Class II | |
| K003879 | Instant-View Benzodiazepine (Bzd) Urine Test (Dip Strip) | Alfa Scientific Designs, Inc. | JXM | Class II | |
| K003847 | Modification to Instant-View Methamphetyamine (Meth1000) Urine Test (Cassette) | Alfa Scientific Designs, Inc. | LAF | Class II | |
| K003845 | Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip) | Alfa Scientific Designs, Inc. | LAF | Class II | |
| K003836 | Synthes Synex Spacer System | Synthes GmbH | MQP | Class II | |
| K003733 | Scs Closed Screw | Ortho Tec, LLC | MNH | Class II | |
| K003647 | Instant-View Barbiturate Urine Cassette Test | Alfa Scientific Designs, Inc. | DIS | Class II | |
| K003630 | Danmar Products Michigan Cranial Helmet | Danmar Products, Inc. | MVA | Class II | |
| K002058 | Vectorsurge 5, Model Vs-500 | Metron Medical Australia, Pty, Ltd. | IPF | Class II | |
| K011381 | Hummer IV Microdebrider System | Stryker Corp. | ERL | Class II | |
| K011376 | Evergreen and Multiple Private Labels Non-Sterile Powdered Latex Patient Examination Gloves, with Protein Labeling (200 | Yty Industry (Manjung) Sdn. Bhd. | LYY | Class I | |
| K011287 | Radius Cougar Wire | Radius Medical Technologies, Inc. | DQX | Class II | |
| K011186 | Powder-Free Sterile Synthetic Vinyl Examination Gloves | Medtronic, Inc. | LYZ | Class I | |
| K010947 | Snow Lotus Powder Free Latex Examination Gloves with a Protein Content Labeling Claim (50 Micrograms or Less) | Beijing Reagent Latex Products Co., Ltd. | LYY | Class I | |
| K010763 | Goodnet | Goodman Co., Ltd. | LLZ | Class II | |
| K010583 | Ambu Gel, Hydrogel Burn Dressing | Ambu, Inc. | MGQ | Unclassified | |
| K010563 | End-to-End and Side-by-Side Connectors | Spinal Concepts, Inc. | MNI | Class II |