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 |
|---|---|---|---|---|---|
| K981993 | Olympus Integrated Endosurgery System Endoalpha | Olympus Optical Co., Ltd. | ODA | Class II | |
| K981568 | Mascot Md Hematology Analyzer, Model Md 800 | Cdc Technologies, Inc. | GKZ | Class II | |
| K981498 | Is-Toxoplasma Igg Test System | Diamedix Corp. | LGD | Class II | |
| K981451 | Argomedical Bipolar System | Globus Medical, Inc. | KWL | Class II | |
| K981238 | Bipolar Femoral Head | Whiteside Biomechanics, Inc. | KWY | Class II | |
| K981120 | Zeus Scientific Inc., Anti-Ebv Ea Igg Elisa | Zeus Scientific LLC | LSE | Class I | |
| K981028 | Ultra Image and Ultra Scan | Sonotech, Inc. | ITX | Class II | |
| K980976 | Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap | Hollister, Inc. | HDB | Class II | |
| K980885 | Shield Activated Factor XII (Elisa) Assay | Shield Diagnostics, Ltd. | GGP | Class II | |
| K980238 | Gynex Extended Reach Needle | Gynex Corp. | HEE | Class II | |
| K974269 | Sa8800 Diagnostic Ultrasound System and Transducers, | Medison America, Inc. | IYN | Class II | |
| K972587 | Electrocardiographs | Dr. Lee Co., Ltd. | LOS | ||
| K982755 | Modification of Autotransfusion Apparatus (Autolog) | Medtronic Blood Management | CAC | Class II | |
| K982626 | Urethropexy Suture Placement Kit Model Numbers Um-300, Mw-100, Mini-Laparotomy Mmk Kit Model Um-250, Laparoscopic Burch0 | Medworks Corp. | EZL | Class II | |
| K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson MEDICAL GmbH | KGN | Unclassified | |
| K982112 | Thermatrek Iris-3 Infrared Imaging System | Thermatrek | LHQ | Class I | |
| K981969 | Ultima Body Position Sensor | Braebon Medical Corp. | LEL | Class II | |
| K981939 | Autocorr Plus; 3404 Oximeter/ecg Monitor | Bci Intl., Inc. | DQA | Class II | |
| K981870 | Visage Cosmetic Surgery System | ArthroCare Corporation | GEI | Class II | |
| K981747 | Biotrans Pressure Monitoring Kit Model Number Bt Xxxxxx | Sunscope Intl., Inc. | DRS | Class II | |
| K981636 | Integrated Drive/pump System | Linvatec Corporation | HRX | Class II | |
| K980995 | Plaq-Ataq-I | Ethicare | EFW | Class I | |
| K980619 | Sabratek Patient Home Management System | Sabratek Corp. | MHX | Class II | |
| K980411 | Npb3900 Series Patient Monitors | Analogic Corp. | MHX | Class II | |
| K980390 | Pta Balloon Catheter | Cook Inc. | LIT | Class II | |
| K982608 | Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa Kit | Sangui Biotech, Inc. | CKG | Class II | |
| K982469 | Hichem Cholesterol Reagent Kit | Elan Pharma, Inc. | CHH | Class I | |
| K982383 | Platex Gentle Glide, Silk Glide, Slimfits, Soft Comfort and Portables Tampons | Playtex Products, Inc. | HIL | Class II | |
| K982289 | Heat Probe Unit Hpu-20, Heat Probe Cd-110##/120## | OLYMPUS Corporation of the Americas | KNS | Class II | |
| K981807 | Cardiovision Software, Model S-Cv5-96 | SHL TeleMedicine International | DPS | Class II | |
| K981130 | Ksea Endo Tip System | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K980884 | Siemens Sevoflurane Vaporizer Sv 953 | Siemens Medical Solutions USA, Inc. | CAD | Class II | |
| K963271 | Futrex-6100/Xl | Futrex, Inc. | MNW | Class II | |
| K982770 | 6F Envoy Guiding Catheter | Cordis US Corp. | DQY | Class II | |
| K982632 | Envoy and Vista Brite Tip | Cordis US Corp. | DQY | Class II | |
| K982551 | Roche C0bas Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum Barbiturates Calibrators, Roche Cobas in | Roche Diagnostic Systems, Inc. | DIS | Class II | |
| K982395 | Dytract Flow Restorative | Dentsply Intl. | EBF | Class II | |
| K982377 | Opc Lowwear Porcelain | Jeneric/Pentron, Inc. | EIH | Class II | |
| K982327 | Inframetrics Infracam-Med | Inframetrics, Inc. | LHQ | Class I | |
| K982267 | Dpx-Rx Bone Densitometer | Lunar Corp. | KGI | Class II | |
| K982263 | Mb/bact Blood Culture Bottle | bioMerieux, Inc. | MDB | Class I | |
| K982251 | Sigma Diagnostics Infinity Uric Acid Reagent Kit | Sigma Diagnostics, Inc. | CDO | Class I | |
| K982087 | Roche Crp T Control N | Roche Diagnostic Systems, Inc. | DCK | Class II | |
| K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | JAK | Class II | |
| K981962 | Cuda Products Corp. Model M300 (M-300) Lightsource | Cuda Products Co. | FSS | Class II | |
| K981953 | Various Trade Tampons Sold Under Private Labels | Paragon Trade Brands, Inc. | HEB | Class II | |
| K981948 | Apollo 95E | Dental/Medical Diagnostic Systems, Inc. | EBF | Class II | |
| K981905 | Sterile Saline Solution 0.9%- Catalog No, 10290, Sterile Water- Catalog No. 10291 | Acu-Pak | FOZ | Class II | |
| K981892 | Quick & Sure Onestep Home Pregnancy Test | Abacus Diagnostics | LCX | Class II | |
| K981890 | Synthes (USA) [Synthes] Mmfs - 2.0 Mm Sagittal Split Plates | Synthes (USA) Products LLC | JEY | Class II |