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 |
|---|---|---|---|---|---|
| K060686 | Microlife Automatic Blood Pressure Monitor, Model Bp3ac1-1Pc | Microlife Intellectual Property GmbH | DXN | Class II | |
| K060526 | Tipi | Contipi, Ltd. | HHW | Class II | |
| K060402 | Brightway Brand Nitrile Examination Glove (Powder Free, Black Colour) | Brightway Holdings Sdn. Bhd. | LZA | Class I | |
| K053444 | Kowa Kt-800 | Kowa Co., Ltd. | HKX | Class II | |
| K053172 | Universal-X (USA) or /Krystal-X (Europe) | Owandy SAS | MUH | Class II | |
| K052764 | Diacap Ultra Dialysis Fluid Filter | B. Braun Medizintechnologie GmbH | FKQ | Class II | |
| K052493 | Socket Graft | Steiner Laboratories | LYC | Class II | |
| K052197 | First Sign Drug of Abuse Urine Screening Test | W.H.P.M., Inc. | DJR | Class II | |
| K061435 | Medela Vario Suction Pumps | Medela AG | OMP | Class II | |
| K061380 | Retain Radiolucent Spacer | Globus Medical, Inc. | MQP | Class II | |
| K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | HRS | Class II | |
| K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | MBI | Class II | |
| K061144 | Depuy Cmw 2 and Cmw 3 Gentamicin Bone Cement | Depuy Orthopaedics Inc. | MBB | Class II | |
| K061047 | Hemocue Hb 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 | HemoCue AB | GKR | Class II | |
| K061016 | Ebi Esl Peek-Optima Spine System | Ebi, LLC | MQP | Class II | |
| K060916 | Atlas Spinal Cage, Models Sc-150-007, 009, 011, 013, 015, 017. | Spinal Edge, LLC | MQP | Class II | |
| K060858 | Latex Powdered Examination Glove | High Momentum Sdn Bhd | LYY | Class I | |
| K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow Ac Power Supply, Model 120 | Enginivity, LLC | LGZ | Class II | |
| K060488 | Dermatech IV Holder | Dermatech Medical, Inc. | FPA | Class II | |
| K060118 | Ssp Pedicle Screw System | Specialty Spine Products, LLC | MNH | Class II | |
| K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | NUC | Class II | |
| K061355 | Bd Phoenix Automated Microbiology System - Ampicillin (Gn) 0.5-32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K061337 | Wiedent Estetic | Xpdent Corp | ELM | Class II | |
| K061163 | Innova 2121Iq, Innova 3131Iq, Innova 4100, Innova 4100Iq, Innova 3100, Innova 3100Iq, Innova 2100Iq with Innova Ivus Opt | GE Healthcare | OWB | Class II | |
| K061110 | Glucommander Plus | Collaborativemed, LLC | NDC | Class II | |
| K061097 | Coherence Dosimetrist, Model 2.2 | Siemens Medical Solutions USA, Inc. | MUJ | Class II | |
| K061061 | 20.1-Inch (51Cm) Color Lcd Monitor Cdl2009a (Ccl204) | Tokotu Electric Co., Ltd. | LLZ | Class II | |
| K061028 | Precision Thunis 800+ | GE Healthcare | JAA | Class II | |
| K060910 | Powdered Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Jiangsu Everyguard Plastic Products Co., Ltd. | LYZ | Class I | |
| K060820 | Cycle Bp Monitor and Pulse Oximeter, Model 1060 | Suntech Medical, Inc. | DXN | Class II | |
| K060642 | Duteck Body Composition Analyzer | Duteck Industrial Co., Ltd. | MNW | Class II | |
| K060627 | Tag-It Cystic Fibrosis Kit | Tm Bioscience Corporation | NUA | Class II | |
| K060551 | Brivant Guidewire | Brivant, Ltd. | DQX | Class II | |
| K052661 | Quix Digital Radiographic Upgrade | Edge Medical Devices, Ltd. | MQB | Class II | |
| K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium | Biomet Microfixation | HRS | Class II | |
| K061345 | Modification to Endius Atavi System | Endius, Inc. | HRX | Class II | |
| K061312 | 36Mm Biolox Delta Ceramic Heads | Zimmer GmbH | LZO | Class II | |
| K061244 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL | Class II | |
| K061114 | Wds, Size 2 and Size 2 | Cefla S.C.R.L. | MUH | Class II | |
| K061083 | Cts-7700 | Shantou Institute of Ultrasonic Instuments | IYO | Class II | |
| K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | JDS | Class II | |
| K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (Cms Monitor) | Twin Star Medical, Inc. | LXC | Unclassified | |
| K060844 | Silkline Soft Relining Kit, Model 28-100100 | J. Morita USA, Inc. | EBI | Class II | |
| K060693 | Microstrike and Allthread Peek Suture Anchor | Arthrotek, Inc. | HWC | Class II | |
| K060664 | Fastin Rc Anchor | DePuy Mitek, Inc. | HWC | Class II | |
| K060632 | Vitros Immunodiagnostic Products Nt Pro-Bnp Reagent Pack,calibrators,range Verifiers,680 2156,680 2157,680 2158 | Ortho-Clinical Diagnostics, Inc. | NBC | Class II | |
| K060580 | K-Shield Port Access Infusion Set | Kawasumi Laboratories Co., Ltd. | FPA | Class II | |
| K060463 | Hema Screen Specific Ifobt | Immunostics, Inc. | KHE | Class II | |
| K060389 | Confidose Im Auto-Injector | Pharma-Pen, Inc. | KZH | Class II | |
| K060375 | Bd Multitest 6-Color Tbnk Reagent with Bd Trucount Tubes with Models 337 and 166 | Becton, Dickinson and Company, BD Biosciences | GKZ | Class II |