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 |
|---|---|---|---|---|---|
| K960278 | Cobalt-Chromium-Molybdenum (Co-Cr-Mo) Alloy Femoral Heads W/co-Nidium Surface Treatment | Zimmer GmbH | JDI | Class II | |
| K955828 | Medi-Trace Combination Defibrillation & ECG Electrode for Physio Control Defibrillators | Graphic Controls Corp. | MKJ | Class III | |
| K955606 | Piston Syringe | Medical Surgical Intl. | FMF | Class II | |
| K954378 | Formula IV Electric Mobility Vehicle | Aerotek | INI | Class II | |
| K953811 | Medcomp P-Cath | Medcomp | FOZ | Class II | |
| K952979 | Hanc Network | Healthtech Services Corp. | DXN | Class II | |
| K962326 | Sterngold Bio-5 (1127210) | Sterngold/Implamed | EJT | Class II | |
| K962325 | Quasar Yellow Crown and Bridge Alloy (1122015) | Sterngold/Implamed | EJT | Class II | |
| K962324 | Sterngold U-Cpf Metal Alloy (1067800) | Sterngold/Implamed | EJS | Class II | |
| K962122 | Sentry Radiotranslucent ECG Electrodes | Sentry Medical Products, Inc. | DRX | Class II | |
| K962091 | Polarus Af Rod | Acu Med, Inc. | HSB | Class II | |
| K962047 | Titanium Cannulated Tibial Nail (Ti Ctn) | Synthes (USA) Products LLC | JDS | Class II | |
| K962016 | Medline Titanium Hemoclips | MEDLINE INDUSTRIES, LP - Northfield | FZP | Class II | |
| K961371 | Subcutaneous Urinary Diverson Stent Set | Cook Incorporated | FAD | Class II | |
| K961012 | Vzv Igg Elisa Test System | Zeus Scientific LLC | LFY | Class II | |
| K960936 | Resposable Trocar System [5Mm, 5Mm Short, 10Mm and 12Mm Sizes] | Origin Medsystems, Inc. | HET | Class II | |
| K960176 | Davol Nasogastric Sump Tube W/prevent Filter | C.R. Bard Inc | FEG | Class II | |
| K960083 | Movable Cantilevered Radiographic Table Xrt 100, 200 & 300 | Wuestec Medical, Inc. | IXQ | Class II | |
| K955414 | Xrt 400 | Wuestec Medical, Inc. | KXJ | Class II | |
| K955363 | Incstar Hsz i/ii Igg Elisa Assay | Incstar Corp. | IGC | Class I | |
| K955362 | Incstar Hsv i/ii Igg Fast Elisa Assay | Incstar Corp. | IGC | Class I | |
| K954713 | Dural-Lumen Intra Vascular Balloon Catheter (Modification) | Ideas for Medicine, Inc. | FGE | Class II | |
| K954432 | Crystal & Crystal-Plus Implants System | Crystal Medical Technology | DZE | Class II | |
| K951851 | Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay | E.I. Dupont de Nemours & Co., Inc. | LJO | Class II | |
| K962674 | Sta - Vwf Control [N]+[p] Kit | American Bioproducts Co. | GGN | Class II | |
| K962431 | Ctm Disposable Pak | Circuit Tree Medical, Inc. | HQC | Class II | |
| K962430 | Ctm Reusable Pak | Circuit Tree Medical, Inc. | HQC | Class II | |
| K962304 | Sterngold Bio-4 | Sterngold/Implamed | EJS | Class II | |
| K962219 | Quickstick One Step Pregnancy Test(9010) | Phamatech Inc. | LCX | Class II | |
| K961824 | Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin | Roche Diagnostic Systems, Inc. | DCF | Class II | |
| K961658 | Megatron Ophthalmic Surgical System | Intl. Ophthalmic Industries Corp. | HQC | Class II | |
| K961586 | Uric Acid-Sl Assay Catalogue No. 237-60 | Sekisui Diagnostics P.E.I. Inc. | KNK | Class I | |
| K961577 | Prism 3000Xpv System (210714) | Philips North America LLC | KPS | Class II | |
| K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | HWC | Class II | |
| K960539 | Diao Hand Surgery Set | Kinetikos Medical, Inc. | HXB | Class I | |
| K955815 | G3000 or Ag2000; Disposable Resting Electrode | Cmc Sense-It, Inc. | DRX | Class II | |
| K954326 | Stc Diagnostics Auto-Lyte Urinary Hemoglobin Assay | Solarcare Technologies Corp,Inc. | JIT | Class II | |
| K953875 | Crit-Line Hematocrit Alert (Modification) | In-Line Diagnostics Corp. | MQS | Class II | |
| K943503 | Chemcard Glucose Test | Chem-Elec, Inc. | CGA | Class II | |
| K962694 | Opus B12 Controls | Behring Diagnostics, Inc. | JJX | Class I | |
| K962630 | Document Ammonia, Ethanol, Lactate Assayed Control | Casco Standards | JJY | Class I | |
| K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | JJY | Class I | |
| K962574 | Waters 474 Scanning Flourescence Detector (474) | Waters Corporation | LEQ | Class I | |
| K962573 | Elecsys Precicontrol Tsh | Boehringer Mannheim Corp. | JJX | Class I | |
| K962416 | Drytime for Bladder Control Silent | Bio-Systems Research | KPN | Class II | |
| K962374 | Fiber-Splint Ml Multilayer | Polydentia USA | EBI | Class II | |
| K962168 | Mucus Specimen Trap | Sage Products LLC | KDQ | Class II | |
| K962130 | Branemark Systems Mkii Selk-Tapping Fixture | Nobelpharma USA, Inc. | DZE | Class II | |
| K961762 | Reusable Endoscopic Accessory Handle | United States Endoscopy Group, Inc. | KNS | Class II | |
| K961750 | Document Cardiac Assayed Control | Casco Standards | JJY | Class I |