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 |
|---|---|---|---|---|---|
| K001764 | Hotline 2 Fluid Warmer | Sims Level 1, Inc. | LGZ | Class II | |
| K001727 | Modification to Blease Frontline Genius Range, Anesthesia Machines | Blease Medical Equipment, Ltd. | BSZ | Class II | |
| K001492 | Quinton Q-Stress, Model 000483 | Quinton, Inc. | DPS | Class II | |
| K001414 | Kwikkmodel | R-Dental Dentalerzeugnisse GmbH | ELW | Class II | |
| K001162 | Goldfinger Device | Mali-Tech, Ltd. | FMK | Class II | |
| K000574 | Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (Active) | WR Medical Electronics Co. | EGJ | Class II | |
| K002258 | Ultraguide CT-Guide 1010 | Ultraguide, Ltd. | JAK | Class II | |
| K002239 | Sigma 110/330 Diagnostic Ultrasound System | Kontron Medical Systems SAS | IYN | Class II | |
| K002225 | Or Table/magnetom Open Viva System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K001978 | 'One Touch' Latex Condom with Nonoxynol-9 | Thai Nippon Rubber Industry Co., Ltd. | LTZ | Class II | |
| K001406 | Ha/gold Total and Partial, Regular and Offset, Ossicular Replacement Prostheses | Mednet Locator, Inc. | ETA | Class II | |
| K001404 | Gold Total and Partial, Regular and Offset, Ossicular Replacement Prostheses, Gold Total with Fountian Head, Gold Piston | Mednet Locator, Inc. | ETA | Class II | |
| K000736 | La Joie | Goomi Ehwa, Inc. | HED | Class I | |
| K000388 | Clearwater Colon Hydrotherapy (Disposable Speculum Spo1 Large & Sp02 Small) | Clearwater Colon Hydrotherapy, Inc. | KPL | Class II | |
| K994395 | Instant-View Amphetamine Urine Cassette Test | Alfa Scientific Designs, Inc. | DKZ | Class II | |
| K984390 | Lactosorb Panels and Fasteners | Zimmer GmbH | HRS | Class II | |
| K002196 | Lyphochek Fertility Control, Models 480, 481, 482, 483 | Bio-Rad | JJY | Class I | |
| K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | CGA | Class II | |
| K001767 | Diamedix Is-Cmv Igm Capture Test System | Diamedix Corp. | LJO | Class II | |
| K001761 | Statlyte Na/k/cl/li Analyzer | Nova Biomedical Corporation | JGS | Class II | |
| K001547 | Etest Esbl Ct/ctl Strip; Etest Esbl Tz/tzl Strip | Ab Biodisk | JWY | Class II | |
| K001471 | The Implex Hedrocel Acetabular Augment, Xx-Yyy-Zzzz | Implex Corp. | LWJ | Class II | |
| K001456 | Consensus Knee System | Hayes Medical, Inc. | JWH | Class II | |
| K001126 | Peace of Mind Multiple Drugs of Abuse Test | Alatex Scientific, Inc. | LDJ | Class II | |
| K994400 | Instant-View Methamphetamine Urine Cassette Test | Alfa Scientific Designs, Inc. | DJC | Class II | |
| K994399 | Instant-View Amphetamine Urine Dip Strip Test | Alfa Scientific Designs, Inc. | DKZ | Class II | |
| K993788 | R.test Evolution | Novacor Div. | MLO | Class II | |
| K993166 | Stryker Bioabsorbable Interference Screw System | Stryker Corp. | HWC | Class II | |
| K992226 | Xds External Csf Drainage and Monitoring System | Radionics, Inc. | JXG | Class II | |
| K992133 | Newport Ht50 Ventilator with Humidifier Ht50-H, Newport Ht50 Ventilator without Humidifier, Ht50-H1, Newport Ht50 Ventil | Newport Medical Instruments, Inc. | CBK | Class II | |
| K991971 | Arthrex Chondral Dart, Model Ar-4005B-18 | Arthrex GmbH | HTY | Class II | |
| K991522 | Microtargeting Electrode | FHC, Inc. | GZL | Class II | |
| K983299 | Allegiance Genesis Container System | Medtronic, Inc. | FRG | Class II | |
| K002170 | Model 9000 Pediatric Wheelchair | Invacare GmbH | IOR | Class I | |
| K002107 | Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/puc Lga. | Scimedx Corp. | MVM | Class II | |
| K001994 | Eei Slush Pan Drape | Eagle Endoscopic, Inc. | KKX | Class II | |
| K001975 | Ceralas D10 810Nm Laser, Model Ceralas D10-60 | Ceram Optec, Inc. | GEX | Class II | |
| K001913 | Clearfil St Opaquer | Kuraray Co. | EBF | Class II | |
| K001808 | Doro Headrest System | Black Forest Medical GmbH | HBL | Class II | |
| K001803 | Accelerator Reciprocating Cannula | Byron Medical | QPB | Class II | |
| K001724 | Stimulan -Calcium Sulfate Bone Void Filter | Biocomposites, Ltd. | MQV | Class II | |
| K001721 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | LTT | Class II | |
| K001645 | Sysmex Automated Coagulation Analyzer, Model Ca-1500 | Siemens Healthcare Diagnostics Inc. | GKP | Class II | |
| K001614 | Stryker Trauma Pelvic Set | Howmedica Osteonics Corp | KTW | Class II | |
| K001571 | Baumer Femoral Head | Baumer S.A. | JDI | Class II | |
| K001476 | Torque Instrument, Model 8500 | Spinalight Inc | LXM | Unclassified | |
| K001470 | E-Z Link Cross Connector | Depuyacromed | KWP | Class II | |
| K001449 | Trident Acetabular Shells: Ps | Howmedica Osteonics Corp | LZO | Class II | |
| K001448 | Trident Acetabular Shells: Ps-Ha | Howmedica Osteonics Corp | MEH | Class II | |
| K001009 | Randox C-Reactive Protein | Randox Laboratories, Limited | DCK | Class II |