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 |
|---|---|---|---|---|---|
| K990434 | Careside Ckmb | Careside, Inc. | JHS | Class II | |
| K990199 | Smartrecorder, Model 2500 | Respironics, Inc. | MNR | Class II | |
| K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp | FLE | Class II | |
| K990159 | Dynamic Hollow Fiber Dialyzer Dh-Series, Model Ah 90111 | Dynamic Technology Corp. | FJI | Class II | |
| K980903 | Radionics Equi-Flow Valve, Ventricular and Peritoneal Catheter with Ez-Coat | Radionics, Inc. | JXG | Class II | |
| K991034 | Convertors Surgical Gowns | Medtronic, Inc. | FYA | Class II | |
| K990928 | Lyphocheck Urine Metals Control, Item No.400, 405 | Bio-Rad | DIE | Class I | |
| K990825 | Revised C-Reactive Protein (Rcrp) Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | DCN | Class II | |
| K990824 | Revised C-Reactive Protein Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K990715 | Shimadzu Ceiling Tube Support Ch-30Gh | Shimadzu Corp. | KPR | Class II | |
| K990458 | Straumann Extraoral Implant System | Straumann USA, LLC | KCZ | Class I | |
| K990406 | Kingli Acupuncture Needle | united pacific Company | MQX | Class II | |
| K990281 | S-38 (Polymacon) Soft (Hydrophilic) Contact Lens, the Esstech Ps & Sv (Polymacon) Soft (Hydrophilic) Contact Lens | Nissel, Ltd. | LPL | Class II | |
| K990248 | Dicom Image Manager, Model 3-D Visualization Option | Dicomit Imaging Systems Corp. | IYO | Class II | |
| K990147 | Bipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771 | Richard Wolf Medical Instruments Corp. | HIN | Class II | |
| K990031 | Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and Accessories | Nihon Kohden America Inc | LOS | ||
| K984446 | `Bi I-125 Brachytheraphy Seed, Model 125Sl & 125Sh | Urocor, Inc. | KXK | Class II | |
| K983948 | Beacon, Model 211060 | Philips North America LLC | KPS | Class II | |
| K983830 | Copperhead 5 Fr. Pta Catheter, Finch 4 Fr. Pta Catheter | Mallinckroot, Inc. | LIT | Class II | |
| K991084 | Accusign Doa3, Doa, Bar/bzo/mtd, Biosign Doa3, Biosign Bar/bzo/mtd | Princeton BioMeditech Corp. | DIS | Class II | |
| K991082 | Accusign Doa2, Doa, Bar/bzo, Biosign Doa2, Bar/bzo, Status Ds Bar/bzo, Syva Rapidtest D.a.u. 2 Bar/bzo | Princeton BioMeditech Corp. | DIS | Class II | |
| K991080 | Accusign Mtd, Biosign Mtd | Princeton BioMeditech Corp. | DJR | Class II | |
| K991079 | Accusign Bzo, Biosign Bzo, Status Bzo | Princeton BioMeditech Corp. | JXM | Class II | |
| K991078 | Accusign Doa8, Doa8 Panel, Thc/opi/coc/amp/bzo/bar/tca/pcp, Biosign Doa8, Thc/opi/coc/amp/bzo/bar/tca/pap, Status Ds Do8 | Princeton BioMeditech Corp. | DKE | Class II | |
| K991076 | Accusign Doa3, Doa3(bzo/bar/pcp), Bzo/bar/pcp, Biosign Doa3, Doa3(bzo/bar/pcp), Bzo/bar/pcp | Princeton BioMeditech Corp. | DIS | Class II | |
| K991018 | Accusign Bar, Biosign Bar, Status Bar | Princeton BioMeditech Corp. | DIS | Class II | |
| K990919 | Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,extended Straight Aspirator,13.9 Cm Strag | Visualization Technology, Inc. | LLZ | Class II | |
| K990759 | View Com | Electromed Intl., Ltd. | LLZ | Class II | |
| K990409 | Ontrak Teststik for Morphine 2000 (M2k) | Roche Diagnostics GmbH | DMY | Class II | |
| K990399 | Ontrak Testcup M2k, Model Cat. 11 1849 8 | Roche Diagnostics GmbH | DKZ | Class II | |
| K990260 | Opart | Toshiba America Mri, Inc. | LNH | Class II | |
| K990010 | Althin Medical Ab Altracart II | Althin Medical AB | KPO | Class II | |
| K984504 | Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and Accessories | Nihon Kohden America Inc | LOS | ||
| K984234 | Quanta Lite Lyme Igm Elisa | Inova Diagnostics, Inc. | LSR | Class II | |
| K984222 | Quanta Lite Lyme Igg Elisa | Inova Diagnostics, Inc. | LSR | Class II | |
| K983341 | Standard Ct/mr Applicator Set,ring Ct/mr Applicator Set, Vaginal Ct/mr Applicator Set, Fletcher Williamson Applicator Se | Nucletron BV | JAQ | Class II | |
| K982132 | Blease 6200 Anaesthesia Ventilator | Blease Medical Equipment, Ltd. | CBK | Class II | |
| K974236 | Medcomp Schon Xl Soft-Line Double Lumen Catheter, 15Cm Sbf146, Medcomp Schon Xl Soft-Line Double Lumen Catheter, 20Cm Sb | Medical Components, Inc. | MPB | Class II | |
| K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | BZD | Class II | |
| K990999 | Modification of: Ebi Spinelink System | Electro-Biology, Inc. | MAI | Class II | |
| K990895 | Oxycon Lens | Concise Contact Lens Co. | HQD | Class II | |
| K990595 | Integra Reagent Cassette for Apolipoprotein B | Roche Diagnostics GmbH | DFC | Class II | |
| K990594 | Integra Reagent Cassette for Apolipoprotein a-1 | Roche Diagnostics GmbH | DER | Class II | |
| K990417 | Dermacool | Optomed | GEX | Class II | |
| K990414 | Smith & Nephew Handport System | Smith & Nephew, Inc. | GCJ | Class II | |
| K990361 | Headed Bio-Absorbable Corkscrew Model #Ar-1921Bu | Arthrex GmbH | MAI | Class II | |
| K990332 | Dumex Iodoform Packing Strip | Dumex Medical Surgical Products, Ltd. | FRO | Unclassified | |
| K984213 | Nearly Me Retouch Silicone Scar Reduction Sheets | Capital Marketing Technologies, Inc. | MDA | Class I | |
| K982145 | Mega 3 | Mega Motion, Inc. | INI | Class II | |
| K982144 | Mega 4 | Mega Motion, Inc. | INI | Class II |