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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K894497 | Latex Examination Gloves (Powder-Free/hypo-Aller.) | Safeskin Corp. | LYY | Class I | |
| K893499 | Cms Fast Cut, Cms Diamond and Cms Wire Pass | Cmsi | EQJ | Class I | |
| K893380 | Qcr System I and Qcr System II | Bremer Mfg. & Tool Co., Inc. | LGH | Class I | |
| K893377 | Russell-Taylor Intramedullary Knee Fusion Nails | Richards Medical Co., Inc. | HSB | Class II | |
| K892359 | Model Number: Ir204 CO2 Surgical Laser System | Niic U.S.A., Inc. | GEX | Class II | |
| K881334 | Light Coagulator Lc 250 | Nk-Optik GmbH | HAM | Class II | |
| K895841 | Model 8750 Bipolar/monopolar Electrosurgical Gene. | Everest Medical Corp. | GEI | Class II | |
| K895668 | Digicam Lhp (Video Interface Option) | Siemens Gammasonics, Inc. | LMC | Class II | |
| K895545 | V*s*r(tm) Scope | Vsr Enterprises Corp. | LDE | Class I | |
| K895360 | c.p.a.p. Valve and C.p.p.a. Kit | Ballard Medical Products | BYE | Class II | |
| K895233 | Bacterial and Viral Filter | F.L.W. Plastics, Inc. | CAH | Class II | |
| K895204 | Epi-Cath(tm) Epidural Catheter | Abbott Medical | BSO | Class II | |
| K895034 | Buckys Models Ymb-15A, Ymb-15B and Ymb-15C | Yamato Medical Corp. | IXY | Class I | |
| K894928 | Sterile Latex Surgeon's Gloves | Gigantic International Corp. | KGO | Class I | |
| K894714 | 1989 Software Revision to the Bmt-1100 | Bruker Medical Imaging, Inc. | LNH | Class II | |
| K894367 | Leukosport(tm) Adhesive Tape | Beiersdorf, Inc. | KGX | Class I | |
| K894088 | Teca Neuromapper 1620, Brain Mapper | Teca, Inc. | OLT | Class II | |
| K894056 | Positron Emission Computed Tomograph Set-1400W | Shimadzu Medical Systems | KPS | Class II | |
| K896028 | Glucose-Hexokinase Reagents 4470030,050,300,600 | American Research Products Co. | CFR | Class II | |
| K895822 | Total Bilirubin L.f. | Sclavo, Inc. | CIG | Class II | |
| K895778 | Quantimetrix Bilirubin Calibrators | Quantimetrix Medical Industries | JIS | Class II | |
| K895753 | Brevet Disposable Connectors | Brevet Inc. | DQY | Class II | |
| K895664 | Technicon Dax System - Potassium (Ise) Method | Technicon Instruments Corp. | CEM | Class II | |
| K895583 | Accuprobe Neisseria Gonorrhoeae Culture Confirma. | Hologic, Inc. | LSL | Class II | |
| K895455 | Seldinger Percutaneous 2 Pc Needles | Advance Medical Designs Inc | DRC | Class II | |
| K895454 | Seldinger Single Wall; Style I & II (Flashback) | Advance Medical Designs Inc | DRC | Class II | |
| K895214 | Hemostasis Valve | Applied Vascular Devices, Inc. | DYB | Class II | |
| K894712 | Accuprobe Campylobacter Culture Confirmation | Hologic, Inc. | LQO | Class I | |
| K894711 | Accuprobe Group B Streptococcus Culture Confirma. | Hologic, Inc. | GTZ | Class I | |
| K894471 | Surgiprobes and Surgiscalpes in Head/neck Surgery | Surgilase, Inc. | GEX | Class II | |
| K893926 | Sonoca Ultrasonic Surgical System | Holl Meditronics, Inc. | LFL | Unclassified | |
| K893829 | Powered Eye Wash | Sacks Model Makers | MSI | Class III | |
| K893041 | New Adhesive, Pellethan on Polyurethane Leads-Modi | Telectronics Pacing Systems, Inc. | DTB | Class III | |
| K891338 | Smylon (Dental Stain Eraser) | The Smylon Co. | MAU | Class I | |
| K896321 | No. 34100 - 8 Fr & No. 34400 - 14 Fr Closed Trach. | Superior Healthcare Group, Inc. | BSY | Class I | |
| K896001 | Alanine Aminotransferase (Alt) | American Monitor Corp. | CKA | Class I | |
| K895969 | Radkor Dxg-650R | Radkor, Inc. | IZO | Class I | |
| K895914 | Abbott Imx Ige | Abbott Medical | DGC | Class II | |
| K895796 | Api Uniscept Kb | Analytical Products, Inc. | JWY | Class II | |
| K895585 | Hi Chem Triglycerides Calibrator E (88185) | Hichem Diagnostics | JIS | Class II | |
| K895560 | Modified Homeclinic Pregnancy Test | Vanguard Biomedical Corp. | LCX | Class II | |
| K895546 | Modified Spantron Frame Freeze | Spantron, Inc. | JAA | Class II | |
| K895394 | Mobile X-Ray Television Unit Wha-10A/b | Shimadzu Corp. | JAA | Class II | |
| K895390 | Cards O.s. (Tm) Hcg-Urine | Pacific Biotech, Inc. | JHI | Class II | |
| K895251 | Bard Intravaginal Stim. Kit W/(ives(tm)) | C.R. Bard Inc | KPN | Class II | |
| K895123 | 5.0 Mhz Convex Array Intravaginal Transducer | Advanced Technology Laboratories, Inc. | HGL | Class II | |
| K894954 | .22 & 1.2 Micron IV Filters | Vygon Mfg | FPB | Class II | |
| K894328 | Tdx(r) Lites(tm) Lithium | Abbott Medical | JIH | Class II | |
| K896154 | Para Tech for Technicon H-1 | Streck Laboratories, Inc. | JCN | Class II | |
| K896092 | Alkaline Phosphatase, Leukocyte, Kit | Sigma Chemical Co. | GHD | Class I |