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 |
|---|---|---|---|---|---|
| K910905 | Sfa-II Microprocessor-Controlled Module | Life Sciences Manufacturing, Inc. | DRQ | Class II | |
| K910652 | Spinal Tap Needle | Gesco Intl., Inc. | BSP | Class II | |
| K910634 | Dc200 Defibrillator | Siemens Burdick, Inc. | LDD | Class II | |
| K910492 | Bard Replacement Gastrostomy Tube | C.R. Bard Inc | KGC | Class II | |
| K910229 | Soft Tissue Suture Washer/3 Hole Washer | Depuy, Inc. | HTN | Class II | |
| K904899 | Vital Signs Code Blue Adult Manual Resuscitator | Vital Signs, Inc. | BTM | Class II | |
| K904883 | Optyx | Baxter Healthcare Corporation | JXG | Class II | |
| K904496 | Cromatest Syphilis Diagnostic | Biotrax, Inc. | GMQ | Class II | |
| K904032 | Elite II Electrocardiograph | Burdick Corp. | LOS | ||
| K903565 | E560 Electrocardiograph | Burdick Corp. | LOS | ||
| K912542 | Puritas 100% Cotton Absorb Oper Room Surg Towels | Puritas Health Care, Inc. | KKX | Class II | |
| K911827 | Model 5866-9M & Model 6981M | Metronic, Inc. | DTD | Class II | |
| K911825 | Trip(tm) Nasogastric Sump Catheter | Tonometrics, Inc. | FFT | Class I | |
| K912733 | Amerlex-M Specific Estrol(unconjugated) Ria Kit | Amersham Corp. | CIG | Class II | |
| K912729 | Emit Calibrator B Level 1(Cutoff) & Level 2(High) | Syva Co. | DKB | Class II | |
| K912680 | Antigenz Chlamydia | Baxter Diagnostics, Inc. | LJC | Class I | |
| K912234 | Somniprobe(r) Model Number 10093, Modification | Somnitec, Inc. | BZG | Class II | |
| K912225 | 3M Digital Recording Automatic Film Handling Unit | 3M Medical Products Group | IXW | Class II | |
| K912007 | Baxter Single Patient Use Blood Pressure Cuff | Tecnadyne Scientific, Inc. | DXQ | Class II | |
| K911935 | Cardiac Electrophysical Lead Selector, Modified | Gould, Inc. | DRR | Class II | |
| K911853 | Pulsatile Anti-Embolism Sys.pump | Baxter Healthcare Corporation | JOW | Class II | |
| K911358 | Cmd/dlco Diagnostic Spirometer | Spirometrics, Inc. | BTY | Class II | |
| K911216 | Infusable | Biomedical Dynamics, Inc. | KZD | Class I | |
| K910895 | Surgical Gloves | Influx Pacific Sdn. Bhd. | KGO | Class I | |
| K910648 | Therapy Chair System | Radiation Technology, Inc. | JAI | Class II | |
| K910169 | Fetalgard 2000 | Analogic Corp. | HGM | Class II | |
| K910002 | Genesys and the Roi | The Complete Systems Corp. Genesys | JAI | Class II | |
| K905752 | Argon Beam Combo Laparoscopic Electrode | Beacon Laboratories, Inc. | GEI | Class II | |
| K905633 | Human C-Reactive Protein Rid Kit | The Binding Site | DCK | Class II | |
| K905435 | Uniquant | Neuroconcepts, Inc. | GWQ | Class II | |
| K905168 | Hyperlite | S.O.S., Ltd. | CBF | Class II | |
| K904918 | Belscope Laryngoscope | Avulunga Pty., Ltd. | CCW | Class I | |
| K903734 | Advantage Ep | Clark Davis Medical Systems, Inc. | GWE | Class II | |
| K912723 | Posey Cufflator | Posey Co. | BSK | Class II | |
| K912797 | Perry Natural Powder Free Gloves | Smith & Nephew, Inc. | KGO | Class I | |
| K912761 | Surgical Saw Blades | Blairden Precision Instruments, Inc. | GFA | Class I | |
| K912633 | Salter Labs Infant Medium Concentration Mask | Salter Labs | BYG | Class I | |
| K912543 | Micro Albumin Eia Test Kit | Immuno Diagnostic Center, Inc. | JIR | Class I | |
| K912513 | Electrolyte Control | Verichem Laboratories, Inc. | JJR | Class I | |
| K912380 | Laser Beam Localizer for Siremobil 4 | Siemens Medical Solutions USA, Inc. | JAA | Class II | |
| K912246 | Target Microalbuminuria Test | Texas Immunology, Inc. | JIR | Class I | |
| K912024 | Automated Biochemical Analyzer (Wak0-20R & 30R) | FUJIFILM Healthcare Americas Corporation | JJE | Class I | |
| K911991 | Magnetom P8 Magnetic Resonance Diagnostic Device | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K911955 | Olympic Warmette | Olympic Medical Corp. | LDQ | ||
| K911943 | Concept Model 5200 Thermal Therapy System | Burke, Inc. | ILO | Class II | |
| K911873 | X-Marx | Macbrud Corp. Medical Div. | JAC | Class I | |
| K911838 | Roche Reagent for C02 | Roche Diagnostic Systems, Inc. | CHS | Class II | |
| K911826 | Immunocard Hcg One Step (I-S) Test Kit | Disease Detection International, Inc. | JHI | Class II | |
| K911813 | Entree Cannula | Core Dynamics, Inc. | FBM | Class I | |
| K911794 | Cath Sheath Introducer Syst Plus W/unistasis Valve | Cordis US Corp. | DYB | Class II |