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 |
|---|---|---|---|---|---|
| K901033 | Mer Multiplane Rectal Probe (Mrp) | Medical Equipment Resources | IYO | Class II | |
| K900882 | Multi Dopplex, Md-1 | Huntleigh Technology, Inc. | JAF | Class II | |
| K895922 | Metricare Empty Container Systems | The Metrix Company | LHI | Class II | |
| K895910 | Steamline | Propper Mfg Co Inc | JOJ | Class II | |
| K903656 | Patient Examination Gloves | United Rubber Corp. (Sabah) Sdn. Bhd. | LYY | Class I | |
| K902273 | O. B. Pack III | Customed, Inc | HHD | Class I | |
| K902160 | Saba Confort Menstrual Pad | Valle & Assoc. | HHD | Class I | |
| K902000 | Kevtek(tm) Laser Drape/organ Protector/eye Shield | Kevtek Medical Products, Inc. | FZS | Class I | |
| K901814 | Mcgrath Orthopaedic Bone Screws | Mcgrath Surgical, Ltd. | HWC | Class II | |
| K901690 | Whenever(r) Unscented Super Maxi Pad | Marcal Paper Mills, Inc. | HHD | Class I | |
| K901590 | Danek Sacral Hook | Danek Medical, Inc. | KWP | Class II | |
| K901422 | Sciview System, Model Sc1250 and Pixie Imaging Sof | Image Systems, Inc. | LLZ | Class II | |
| K901365 | Laser Forceps Handpiece | Lca, Inc. | GEX | Class II | |
| K901360 | Leveen Peritineo-Venous Shunt | BD Becton Dickinson Vacutainer Systems Preanalytic | KPM | Class II | |
| K901237 | Glove Leak Detector | Utah Medical Products, Inc | LDQ | ||
| K901096 | Lumiscope Alternating Pressure Pad & Pump | Lumiscope Co., Inc. | FNM | Class II | |
| K901065 | Infusion Pump | Kendall Mcgaw Laboratories, Inc. | FRN | Class II | |
| K897073 | Additional Transducers for Use W/sdl 300 | Shimadzu Corp. | ITX | Class II | |
| K896644 | Additional Transducers for Use with Sdu 500 | Shimadzu Corp. | ITX | Class II | |
| K896356 | Au530 Diagnostic Ultrasonic Pulsed Echo System | Esaote Biomedica SpA | IYO | Class II | |
| K896075 | Cadd-Pca Ambulatory Infusion Pumps | Pharmacia Deltec, Inc. | FRN | Class II | |
| K902311 | Genevision - Computer Assisted Chromosome Karyo. | Applied Imaging Corp. | LNJ | Class II | |
| K903631 | Infant Manual Resuscitator (Pmr 2) | Medtronic, Inc. | BTM | Class II | |
| K903607 | Powder Free, Non-Sterile Examination Gloves | Tillotson Rubber Co., Inc. | LYY | Class I | |
| K903578 | Pharmacia Delfia System B2-Micro | Pharmacia, Inc. | JZG | Class II | |
| K903570 | Single Patient Use Infant Disposable Manual Resusc | Medtronic, Inc. | BTM | Class II | |
| K903534 | Surgeon's (Surgical) Gloves | Straitscom | KGO | Class I | |
| K903443 | Modified Single Patient Use Disp Man Resuscitator | Medtronic, Inc. | BTM | Class II | |
| K903438 | Mod Puritan Bennett Sing Patient Dispos Man Resus | Medtronic, Inc. | BTM | Class II | |
| K903427 | Nortech Model 86901000 Electrode | Andover Medical, Inc. | GXY | Class II | |
| K903335 | Systemate Uric Acid (Urca) Item Number 65422 | Em Diagnostic Systems, Inc. | CDO | Class I | |
| K903333 | Creatine Kinase Test (Ck) Item Number 65411 | Em Diagnostic Systems, Inc. | CGS | Class II | |
| K903332 | Systemate Amylase (Amyl) Item Number 65404 | Em Diagnostic Systems, Inc. | JFJ | Class II | |
| K903319 | Magnetic Resonance Diagnostic Device | GE Healthcare | LNH | Class II | |
| K903307 | Temp Marq Temperature Trend Indicator | Marquest Medical Products, Inc. | KPD | Class II | |
| K903296 | Synermed Creatinine Reagent Kit | Synermed, Inc. | CGX | Class II | |
| K903287 | Model 900S Apnea/heart Monitor | Healthdyne, Inc. | BZQ | Class II | |
| K903228 | Emit Ets Plus Ethyl Alcohol Assay | Syva Co. | DMI | Class II | |
| K903225 | Challenge Brand Liquid Multi-Enzyme Linearity Cont | Medical Analysis Systems, Inc. | JJY | Class I | |
| K903197 | Aspartate Aminotransferase Test | Em Diagnostic Systems, Inc. | CIT | Class II | |
| K903190 | Moni-Trol Xl and L Unassayed Liquid Chemistry | Medical Analysis Systems, Inc. | JJY | Class I | |
| K903152 | Emit Ethyl Alcohol Calibrators and Controls | Syva Co. | DKB | Class II | |
| K902960 | Milenia(tm) Pcp | Siemens Healthcare Diagnostics Inc. | LCM | Unclassified | |
| K902814 | Suction Catheter, Sterile | Orion Life Systems, Inc. | BSY | Class I | |
| K902732 | Kodak X-Omat 460 Ra Processor | Eastman Kodak Company | IXW | Class II | |
| K902677 | Steri-Shield | Biomedical Devices, Inc. | FXY | Class II | |
| K902648 | Pinnacle Image Processing System | Medasys, Inc. | LLZ | Class II | |
| K902611 | I.c. Medical Smoke Evacuator Activator | I.C. Medical, Inc. | FYD | Class II | |
| K902558 | Collagen Shield for Acute Care | Vitaphore Corp. | MOE | Class I | |
| K902557 | Xpeed Computed Tomography X-Ray System | Toshiba America Medical Systems, In.C | JAK | Class II |