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 |
|---|---|---|---|---|---|
| K001388 | Data Master Perfusion Monitoring System | Dideco S.p.A. | DRY | Class II | |
| K001378 | Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736 | Bionx Implants, Inc. | MAI | Class II | |
| K994398 | Instant-View Cocaine (Benzylecgonine) Urine Cassette Test | Alfa Scientific Designs, Inc. | DIO | Class II | |
| K990119 | Epi-Star Surgical Laser Syster | Nidek, Inc. | GEX | Class II | |
| K002192 | Dermaguard Pf Brown Powder Free Latex Surgical Gloves; Model Style 38 | Ansell Perry | KGO | Class I | |
| K002106 | New Bio-Moore Endo Head, Taper Adapter | Zimmer GmbH | JDI | Class II | |
| K002049 | Inverness Medical Early Pregnancy Test | Selfcare, Inc. | LCX | Class II | |
| K001753 | Medis 5Mp2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | LLZ | Class II | |
| K001748 | Medis 5Mp2 Quad-Head Medical Diagnostic Display System | Barco NV Display Systems | LLZ | Class II | |
| K001745 | Modification to Provident Hip System | Globus Medical, Inc. | LWJ | Class II | |
| K001739 | Polymer Coated Powder-Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein P | Medtronic, Inc. | LYY | Class I | |
| K001728 | Hardy Disk Clarithromycin, 15Mcg | Hardy Diagnostics | JTN | Class II | |
| K001616 | Modification to Syringe Prefilled with 0.9% Sodium Chloride | Abbott Medical | FOZ | Class II | |
| K001536 | Inter-Op Metasul Hooded and Protrusio Acetabular Inserts | Sulzer Orthopedics, Inc. | KWA | Class III | |
| K001527 | Fotona Fidelis Er: Yag Laser System and Accesories | Fotona D.D. | GEX | Class II | |
| K001419 | Solar Shoulder Offset Humeral Head | Howmedica Osteonics Corp | HSD | Class II | |
| K001385 | Howmedica Osteonics Radial Head Prothesis | Howmedica Osteonics Corp | KWI | Class II | |
| K001374 | Patient Matched Cobalt Alloy Trochlea Replacement | Biomet Manufacturing Corp | KRR | Class II | |
| K001372 | E-Z Link Cross Connector | Depuyacromed | KWP | Class II | |
| K001349 | Cardiovise ECG Interpretative Software | Inovise Medical, Inc. | MWJ | Class II | |
| K000050 | Top Quality Chlorinated-Powderfree Examination Gloves | Top Quality Mfg., Inc. | LYY | Class I | |
| K990365 | Gastric Lavage Valve | T-Med Vac Corporation | KNT | Class II | |
| K002033 | Bd Insyte Autoguard -P and Bd Insyte Autoguard -P Winged IV Catheters | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K001982 | Tri-Lock Hip Stem | Depuy Orthopaedics Inc. | LPH | Class II | |
| K001959 | Powdered Sterile Latex Surgical Glove, with Protein Content Labeling Claim (200 Micrograms or Less) | Hartalega Sdn Bhd | KGO | Class I | |
| K001950 | Optical Tracking System (Ots) | Radionics, Inc. | HAW | Class II | |
| K001836 | Nitrile Examination Gloves, Pre-Powdered, Color White | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | |
| K001619 | Multisafe Powder Free Nitrile Gloves, Non Sterile (Blue) | Multisafe Sdn Bhd | LZA | Class I | |
| K001497 | Multisafe-Powdered Nitrile Gloves, Non-Sterile (Blue) | Multisafe Sdn Bhd | LZA | Class I | |
| K001466 | Vocom Silicone System | Smith & Nephew, Inc. | MIX | Class II | |
| K001445 | Smilie Pc | Julie Alliance | EIA | Class I | |
| K001369 | Respievents, Version 4.2 | Non-Invasive Monitoring Systems, Inc. | DQK | Class II | |
| K001350 | Patient Matched Titanium Alloy Trochlea | Zimmer GmbH | KRR | Class II | |
| K001340 | Stackable Cage System | Depuyacromed | MQP | Class II | |
| K001092 | Generic Blood Glucose Test Strip | Inbios Intl., Inc. | CGA | Class II | |
| K000887 | Drx Hba1c | Metrika, Inc. | LCP | Class II | |
| K002115 | A&d Medical Lifesource Ub-401Pc & Ub-401 Digital Blood Pressure Monitors | A and D Engineering, Inc. | DXN | Class II | |
| K001989 | Coonrad/morrey Total Elbow. Model 32-8105 Series | Zimmer GmbH | JDC | Class II | |
| K001957 | Modular Rotating Hinge Knee Tibial Rotating Component | Howmedica Osteonics Corp | KRO | Class II | |
| K001942 | Sl-Plus and Slr-Plus Stems | Plus Orthopedics | LWJ | Class II | |
| K001608 | Blaine Scarcare Patch | Blaine Labs, Inc. | MDA | Class I | |
| K001375 | Ultimate N-Dex Power Free Nitrile Exmination Glove (Tested for Use with Chemotherapy Drugs) | Best Manufacturing Company | LZA | Class I | |
| K001323 | Nuvasive Percutaneous Transfacet/intrapedicular Screw | NuVasive Inc | MRW | Unclassified | |
| K001314 | Medscope | All-Pro Imaging Corp. | HEX | Class II | |
| K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | HRS | Class II | |
| K993706 | Elecsys Serum B-Crosslaps/serum Immunoassay | Roche Diagnostics GmbH | JMM | Class I | |
| K002093 | Atrium Lite Mesh | Atrium Medical Corporation | FTL | Class II | |
| K002071 | Softform Soft Tissue Augmentation Tube with Insertion Tool Modifications for Strands and Suture Holes | Tissue Technologies, Inc. | FTL | Class II | |
| K001934 | Wako Autokit Lp(a) & Lp(a) Calibrator/beckman Cx | FUJIFILM Healthcare Americas Corporation | DFC | Class II | |
| K001933 | Wako Autokit Lp(a) & Lp(a) Calibrator/cobas Bio | FUJIFILM Healthcare Americas Corporation | DFC | Class II |