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 |
|---|---|---|---|---|---|
| K072362 | Novalung Surgical Lung Assist (Sla) Membrane Lung | Novalung GmbH | DTZ | Class II | |
| K071833 | Mosaic Devices | Spinal Elements, Inc | OVE | Class II | |
| K071726 | Zuma | Seaspine, Inc. | MQP | Class II | |
| K071271 | Biomet Cable System | Biomet Manufacturing Corp | JDQ | Class II | |
| K071070 | Olympus Dental Implant System | Keystone Dental Inc. | DZE | Class II | |
| K071046 | Synthes Chronos Composite | Synthes (USA) Products LLC | MQV | Class II | |
| K070865 | Expanding Vascular Sheath | Applied Medical | DYB | Class II | |
| K070520 | Pro Qr (Quick Relief) Powder (for Minor External Bleeding from Wounds & Procedures) | Biolife, LLC | QSY | Unclassified | |
| K072045 | Oncontrol Bone Marrow Biopsy System | Teleflex Medical | KNW | Class II | |
| K071931 | Codman Disposable Perforator, Model(s) 26-1222, 26-1223 | Cerenovus, Inc. | HBF | Class II | |
| K071899 | Bis Module for Envoy Patient Monitor | Mennen Medical, Inc. | OLW | Class II | |
| K070484 | Quantrx Female Fertility Test | Quantrx Biomedical Corporation | NGA | Class I | |
| K072789 | Disposable Aem Fixed Tip Electrodes and Handpieces | Encision, Inc. | GEI | Class II | |
| K072685 | Ngarde System | N Spine, Inc. | NQP | Class II | |
| K072638 | Roche/hitachi Urinary/csf Protein with Model(s) Cat #11877801 | Roche Diagnostics GmbH | JGQ | Class II | |
| K072488 | Lanfan Powder-Free Vinyl Exam Gloves | Shanghai Lanfan Co., Ltd. | LYZ | Class I | |
| K072426 | Atlas Spine Pedicle Screw System | Atlas Spine, Inc. | NKB | Class II | |
| K072402 | Flex-Star V | Cmp Industries, LLC | EBI | Class II | |
| K072339 | Nuvasive Anterior Lumbar Plate System | NuVasive Inc | KWQ | Class II | |
| K072235 | Pm-50 Pulse Oximeter and Vs-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | DQA | Class II | |
| K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/silver Chloride Reusable | Technomed Europe | GXY | Class II | |
| K071986 | Ltm-Rc Surgical Mesh | LifeCell Corp | FTM | Class II | |
| K071937 | Bonalive Granules and Bonalive Plates | Vivoxid, Ltd. | KKY | Class II | |
| K071838 | Neoss Various Titanium Abutments | Neoss, Ltd. | NHA | Class II | |
| K071796 | Capsew Plication System | Cayenne Medical Inc. | GAT | Class II | |
| K071617 | Oral Neutralizer | Oral Biotech LLC | LFD | Unclassified | |
| K062932 | Ahlstrom Grade 226 Specimen Collection Paper | Ahlstrom Mount Holly Springs, LLC | JKA | Class II | |
| K072735 | Pulsion Picco-2, Model 8500 | Pulsion Medical Systems AG | DXG | Class II | |
| K072574 | Alphard Cone Beam CT, Model X178 | Takara Belmont Corporation | JAK | Class II | |
| K072516 | Midmark Diagnostics Iqmark Vital Signs Monitor | Midmark Diagnostics Group | MWI | Class II | |
| K072397 | Synoss Synthetic Bone Graft Material | Collagen Matrix, Inc | LYC | Class II | |
| K072255 | Minrad Inc. Nasal Scavenging Circuit | Minrad, Inc. | CBN | Class II | |
| K072125 | Endoscopic Plication System, Eps, Eplicator, Plicator Instrument | Ndo Surgical, Inc. | ODE | Class II | |
| K072050 | Prolong-Ex, Models: Plex-50Cs, Plex-100Cs, Plex-150Cs | Life-Tech, Inc. | BSO | Class II | |
| K072020 | Restoration Adm System | Howmedica Osteonics Corp | MEH | Class II | |
| K072011 | Copd Liquid Oxygen Portable, Model 300P | Copd Partners, Inc. | BYJ | Class II | |
| K071948 | Aequalis Reversed Adapter | TORNIER Inc. | PHX | Class II | |
| K071909 | Prismacomfort, Model Autocontrol 3Xpt with Autoline Xpt 4R | Barkey GmbH & Co. KG | KOC | Class II | |
| K071851 | Hdc Sterile Spider Screw | Hdc S.r.l. | DZE | Class II | |
| K071632 | Perfect Tissue Contouring System II | Coltene /Whaledent AG | EKZ | Class II | |
| K071194 | Raphael Color Asv Ventilator | Hamilton Medical AG | CBK | Class II | |
| K071101 | Tru Rsv | Meridian Bioscience Inc | GOG | Class I | |
| K071013 | Redsense | Redsense Medical AB | ODX | Class II | |
| K070930 | Reprocessed Autosuture Gia Endoscopic Staplers | Sterilmed Inc | NLL | Class II | |
| K070530 | Modification to Passmed Spinal System | Medicrea Technologies | MNH | Class II | |
| K072797 | Ge Logiq I Comapact Ultrasound, Ge Logiq E Compact Ultrasound, Ge Vivid E Compact Ultrasound | General Electric Co. | IYO | Class II | |
| K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K072365 | Sequoia Plus Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound di | IYN | Class II | |
| K072046 | Exactrac 3Rd Party, Exactrac X-Ray 6D 3Rd Party, Exactrac Oem | Brainlab, Inc. | IYE | Class II | |
| K071993 | T-Port Hp Infusion Port | PFM Medical GmbH | LJT | Class II |