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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K803197 | Impl. Programmable Bipolar Card.gen.#274 | Telectronics, Inc. | DXY | Class III | |
| K803124 | Sidos U. | Siemens Corp. | KPQ | Class II | |
| K803120 | Tilting Imaging Table #846T | Quinton, Inc. | KXJ | Class II | |
| K803103 | Techny Rex 3000 Mobile X-Ray Unit | Tecnomed, Inc. | IZL | Class II | |
| K803090 | Sunmaker (Sun Tanning Bed) | Sunmaker, Inc. | LEJ | Class II | |
| K803032 | Pfizer Pz-Slm Rad. Therapy Trtmt. Simul. | Pfizer Medical Systems, Inc. | KPQ | Class II | |
| K803003 | Interpulse Membrane Oxygenation System | Extracorporeal Medical Specialities, Inc. | DTZ | Class II | |
| K802979 | Diasonics Small Parts Scanner | Diasonics, Inc. | IYN | Class II | |
| K802970 | Terumo Hollow Fiber Oxygenator | Terumo America, Inc. | DTZ | Class II | |
| K802756 | Semi-Oval Modular Suntanning Booth | Tannhut | LEJ | Class II | |
| K802717 | Hp Model 4710A ECG Transmitter | Hewlett-Packard Co. | DXH | Class II | |
| K802113 | Sirecust 400 System Patient Monitoring | Analogic Corp. | DPS | Class II | |
| K810033 | Corti-Shure | Nuclear Medical Laboratories, Inc. | CGR | Class II | |
| K810003 | 'No-Boil' Folic Acid Kit | Siemens Healthcare Diagnostics Inc. | |||
| K803278 | Luteinizing Hormone Radioimmunoassay Kit | Immuno Nuclear Corp. | CEP | Class I | |
| K803219 | Adc-500 Automated Differ. Cell Cntr. Sy. | Abbott Medical | GKZ | Class II | |
| K803206 | Suction Probe | Bemis Health Care | JOL | Class II | |
| K803204 | Irrigation Piston | Walpak Co. | FMF | Class II | |
| K803200 | Irrigation Set W/bulb Syringe | Walpak Co. | KYZ | Class I | |
| K803186 | Normal and Elevated Control for Glyco. | Applied Clinical Research Laboratories | LCP | Class II | |
| K802765 | Acrodisc Filter Assembly | Gelman Sciences, Inc. | FPB | Class II | |
| K802754 | Immunoreactive Estriol Ria Kit | Microanalytic Research, Inc. | CGI | Class I | |
| K802438 | Mark V Duplex Ultrasonic Scan Sys. | Advanced Technology Laboratories, Inc. | ITX | Class II | |
| K810028 | Fetal Blood Sampling Kit Model 1560 | Transidyne General Corp. | HGW | Class II | |
| K810008 | Alp-Kii | Martin'S Maine Exchange | DXQ | Class II | |
| K810002 | 'No-Boil' Vitamin B12 Kit | Siemens Healthcare Diagnostics Inc. | CDD | Class II | |
| K810001 | 'No-Boil' Dualcount Kit | Siemens Healthcare Diagnostics Inc. | CGN | Class II | |
| K803309 | Vitastat ECG-1/Ecg-3 Electrocardiograph | Advanced Technology Laboratories, Inc. | DPS | Class II | |
| K803305 | Dupont 'Aca' Creatine Kinase Verifiers | E.I. Dupont de Nemours & Co., Inc. | JJT | Class I | |
| K803301 | Creatine Kinase Reagent | Gilford Diagnostics | CGS | Class II | |
| K803297 | Luquizyme Triglyceride Reagent Set | Amresco, Inc. | CDT | Class I | |
| K803296 | Endab Cholylglycine Enzyme Immuno. Kit | IMMUNOTECH s.r.o. | KWW | Class II | |
| K803287 | Cholesterol Reagent Enzymatic | Rai, Inc. | CHH | Class I | |
| K803285 | Photometer | Turner Designs, Inc. | JJQ | Class I | |
| K803281 | Automated Electrophoresis System | Helena Laboratories, Corp. | JJN | Class I | |
| K803280 | Human Growth Hormone-Radioimm. Kit | Immuno Nuclear Corp. | CFL | Class I | |
| K803279 | Follice Stimulating Hormone-Radioimm. Kt | Immuno Nuclear Corp. | CGJ | Class I | |
| K803273 | Prolactin (125) Radioimmunaoassay | Corning Medical & Scientific | CFT | Class I | |
| K803267 | Automated Immuochemistry System | Beckman Instruments, Inc. | JJE | Class I | |
| K803231 | Thb 6000 Hardshell Bubble Oxygenator | Travenol Laboratories, S.A. | DTZ | Class II | |
| K803182 | Syringe for Blood Sampling | The University of Chicago | GIM | Class II | |
| K803058 | Swan-Ganz Flow-Directed Multipur. Cath. | American Edwards Laboratories | LDF | Class II | |
| K802917 | Mark III Ultrasonic Scanning System | Advanced Technology Laboratories, Inc. | DXK | Class II | |
| K802832 | Sandare Glycohemoglobin Procedure | Sandare Chemical Co., Inc. | LCP | Class II | |
| K802816 | Endocardial Leads 414S & 515S | Siemens Elema AB | DTB | Class III | |
| K802553 | Perm. Endocardial Unipolar Wedge Urethan | Daig Corp. | DTB | Class III | |
| K802552 | Perm. Endocardial Unipolar Tined/wedge | Daig Corp. | DTB | Class III | |
| K802547 | Permanent & Temp. Pacemaker Electrode | Daig Corp. | DTB | Class III | |
| K802545 | Cardioplegic Sets | Texas Medical Products, Inc. | DTR | Class II | |
| K802544 | Disposable Quick Release Perfusion Adap | Texas Medical Products, Inc. | DTL | Class II |