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 |
|---|---|---|---|---|---|
| K000076 | Cell-Chex | Streck Laboratories, Inc. | GJR | Class II | |
| K000012 | Immulite Phenobarbital, Models Lkpb1, Lkpb5 | Siemens Healthcare Diagnostics Inc. | DLZ | Class II | |
| K000005 | Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # Lkva1, Lkva5 & L2kva2, L2kva6 | Siemens Healthcare Diagnostics Inc. | LEG | Class II | |
| K994328 | Sepramesh Biosurgical Composite, Model Smbc-Xxx | Genzyme Corporation | FTL | Class II | |
| K994282 | MRI- Flow Analytical Software Package | Medis Medical Imaging Systems, B.V. | LNH | Class II | |
| K994180 | Pulpdent Cavity Preparation III | Pulpdent Corporation | LBH | Class II | |
| K994170 | Hylashield Cl | Biomatrix, Inc. | MRC | Class II | |
| K994144 | Toothbrush Wash | Cal Huech, Inc. | EFW | Class I | |
| K993941 | Ubas | Marukin Diagnostics | KWX | Class II | |
| K993811 | Multisafe Powdered Latex Examination Gloves, Nonsterile | Multisafe Sdn Bhd | LYY | Class I | |
| K993610 | Cytoplast Resorb, Models R-250, Rp-250, Ru-250, Rps-250, Rpl-250 | Osteogenics Biomedical, Inc. | LYC | Class II | |
| K993170 | Medline Breathable, Impervious Disposable Surgical Gowns | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K993117 | Safeskin Pfe-Xtra Powder-Free Latex Examination Gloves, Protein Content 50 Mcg or Less, for Use with Chemotherapeutic Ag | Safeskin Corp. | LYY | Class I | |
| K000387 | Terumo Needle with Locking Sheath | Terumo Medical Corp. | FMI | Class II | |
| K000378 | Bact/alert Mb Culture Bottle | bioMerieux, Inc. | MDB | Class I | |
| K000231 | Triage Bnp Calibration Verification Controls | Biosite Incorporated | JJX | Class I | |
| K000226 | Disposable Powder Free Nitrile Exam Gloves, White Color | Sheen More Ent. Co., Ltd. | LZA | Class I | |
| K000181 | Hardydisk, Carbenicillin, 100Mcg | Hardy Diagnostics | JTN | Class II | |
| K000175 | Hardydisk Ticarillin 75Mcg | Hardy Diagnostics | JTN | Class II | |
| K994417 | Ovum Pick-Up Needles with Aq Coating, Aspiration Needles with Aq Coating | Cook Incorporated | MQE | Class II | |
| K994296 | Dimension C3 Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | CZW | Class II | |
| K994293 | Dimension C4 Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | DBI | Class II | |
| K994291 | Dimension Special Protein Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K994232 | Phalangeal Fixation System | Medcanica, Inc. | HTY | Class II | |
| K994151 | Percutx-Injection/aspiration Needle Probes/devices | Ximed/Prosure/Injectx | GAA | Class I | |
| K994097 | Medamicus Epidural Introducer | Greatbatch Medical | GZB | Class II | |
| K994087 | Superstitch | Sutura, Inc. | OCW | Class II | |
| K994079 | Reflex Treatment System | Deschutes Medical Products, Inc. | HIR | Class II | |
| K993694 | Mikro-Tip Angiographic Catheter | Millar LLC. | DQO | Class II | |
| K993189 | Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing | Terumo Corp. | DWE | Class II | |
| K992934 | Lemaitre Venous Thrombectomy Catheter | Vascutech, Inc. | DXE | Class II | |
| K992524 | Patient Cables for Monitoring, I.e., ECG, EKG, Spo2, and Bp Interface Cables and Leadwires | Advantage Medical Electronics, Inc. | DSA | Class II | |
| K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | DWJ | Class II | |
| K990330 | Cross Linked Polyethylene Acetabular Components,model Xx-Yy-Zzzzzz | Implex Corp. | JDI | Class II | |
| K000533 | Vocom Implant- 8Mm | Smith & Nephew, Inc. | MIX | Class II | |
| K000504 | Advanta Super Soft Graft | Atrium Medical Corporation | DYF | Class II | |
| K000499 | Advanta Super Soft Graft | Atrium Medical Corporation | DSY | Class II | |
| K000477 | Mdi Ds-DNA Test | Micro Detect, Inc. | LRM | Class II | |
| K000343 | Nac Y-Adp | The Kipp Group | FPA | Class II | |
| K000279 | Stapletac2 Bone Anchor System | American Medical Systems, Inc. | MBI | Class II | |
| K000276 | Mpt 24 and Vital View 24 | Criticare Systems, Inc. | DRG | Class II | |
| K000073 | Mercury Medical Disposable Radiofrequency Cannula | Mercury Medical | GXI | Class II | |
| K000011 | Modified Hydrophilic Coated Guidewire | Lake Region Mfg., Inc. | DQX | Class II | |
| K994205 | Modification of Regular Diameter Single Stage (Rds) Tps Dental Implant System | Lifecore Biomedical LLC | DZE | Class II | |
| K994181 | Pulpdent Cavity Preparation II, Pulpdent Cavity Preparation II Wuth Fluoride | Pulpdent Corporation | LBH | Class II | |
| K992937 | Dental Implant | Nobel Biocare Uas, Inc. | DZE | Class II | |
| K981567 | Hybrid Capture II Ct/gc Test | Qiagen | LSL | Class II | |
| K000394 | Craft Duo-Vac Suction Unit and Craft Suction Unit | Rocket Medical | MQG | Class II | |
| K000367 | Securmix | Eurospital S.p.A. | LHI | Class II | |
| K000230 | Triage B-Type Natriuretic Peptide (Bnp) Controls | Biosite Incorporated | JJX | Class I |