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 |
|---|---|---|---|---|---|
| K981802 | Zoll Stat*padz Adult Multi-Function Electrodes Model Number 8900-4003 | ZOLL Medical Corporation | MKJ | Class III | |
| K981651 | Ab Flu Oia | Biostar, Inc. | PSZ | Class II | |
| K981365 | Mahurkar 13.5 Fr Cuffed Catheter with Curved Extensions | Sherwood Medical Co. | MSD | Class II | |
| K984072 | Architect Tsh Mastercheck, List No, 6C52-05 | Bio-Rad | JJX | Class I | |
| K983861 | Distaflo Bypass Graft | Impra, Inc. | DSY | Class II | |
| K983819 | Intergard Knitted Ultra Thin Collagen Coated Vascular Graft and Hemacarotid Patch Ultra Thin | Intervascular, Inc. | DSY | Class II | |
| K983325 | In-Probe II Urodynamic System | Influence, Inc. | FEN | Class II | |
| K982986 | Tubing Blood Flow Meter Model Number Hd-800 | Koven Technology, Inc. | DPW | Class II | |
| K982976 | Ultrasound Workstation, Uiws-300A | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K982956 | Flowmate II Plus, Model #4000 | Spirometrics Medical Equipment Co. | BZG | Class II | |
| K982795 | Philips Bucky Vision | Philips North America LLC | MQB | Class II | |
| K982667 | Micromedics Nasal Septal Button | Micromedics, Inc. | LFB | Unclassified | |
| K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | JAK | Class II | |
| K982416 | Shun-Thai - Safe-Contact, Boston Medical Latex Exam Glove, Shun-Thai Latex Exmination Glove | Shun Thai Rubber Gloves Industry Co., Ltd. | LYY | Class I | |
| K981909 | Baxter Hemostasis Valve Introducers | Baxter Edwards | DYB | Class II | |
| K981357 | Erco-Vac | Ercons, Inc. | LKY | Class II | |
| K981343 | Erco-Ribbon | Ercons, Inc. | LKY | Class II | |
| K983916 | V-Cath Picc (Peripherally Inserted Central Catheter) | Hdc Corp. | FOZ | Class II | |
| K983818 | Mitek Fastin Rc Anchor | Mitek Products | MBI | Class II | |
| K983763 | Spectrum Spirit | Freedom Designs Inc | IOR | Class I | |
| K983549 | Quadrant Anterior Shine | Cavex Holland B.V. | EBF | Class II | |
| K983480 | Bpos-Ivad Stabilizer | Bpos, Inc. | LJT | Class II | |
| K983035 | Custom Flanged Acetabular Component | Zimmer GmbH | LPH | Class II | |
| K983006 | Osteo 5.0Mm Cannulated Screw System | Stryker Osteonics | HWC | Class II | |
| K982978 | Model 340Ge-21C Quadrature Brain Coil | Medical Advances, Inc. | MOS | Class II | |
| K982971 | Oratec Tac-C, Monopolar Cautery Probe | Oratec Interventions, Inc. | GEI | Class II | |
| K982965 | Endocam Camera Systems 5502/5507 with Cr Camera Heads and Accessories | Richard Wolf Medical Instruments Corp. | FWF | Class I | |
| K982354 | Sd Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12Mm 16Mm 1M | Special Devices, Inc. | HTN | Class II | |
| K981768 | Stealthstation Treatment Guidance Platform | Surgical Navigation Technologies, Inc. | HAW | Class II | |
| K981412 | M1145 (Ups1-1.25K-1G-Mp) Ups | Clary Corp. | CBK | Class II | |
| K981379 | Aurora | Premier Laser Systems, Inc. | GEX | Class II | |
| K981249 | Metered Dose Inhaler-Reusable Model Number Rtc 21-a, Metered Dose Inhaler-Disposable Model Nuber Rtc 21-D | Instrumentation Industries, Incorporated | CAF | Class II | |
| K984074 | Architect Total T4 Mastercheck, List No. 6C49-05 | Bio-Rad | JJY | Class I | |
| K983981 | Bear 1000, Veolar W Leonardo Graphics, Bicore Cp-2000, Bicore Cp-100, Hi-Lo Jet Et Tube | Bear Medical Systems, Inc. | CBK | Class II | |
| K983838 | Abbott Lifecare Standard Tubing Infusion Pump | Abbott Medical | FRN | Class II | |
| K983756 | Surgiform Anatomical Malar | Surgical Technology Laboratories Inc. | LZK | Class II | |
| K983755 | Nasal Dorsal Series | Surgical Technology Laboratories Inc. | FZE | Class II | |
| K983754 | Standard Chin | Surgical Technology Laboratories Inc. | FWP | Class II | |
| K983442 | Abbott Architect Tsh | Abbott Medical | JLW | Class II | |
| K983439 | Abbott Architect Free T3 | Abbott Medical | CDP | Class II | |
| K983434 | Abbott Architect Total T3 | Abbott Medical | CDP | Class II | |
| K983417 | Abbott Architect Free T4 | Abbott Medical | CEC | Class II | |
| K983307 | Modification to Portable Intensive Care Unit | Medical Research Laboratories, Inc. | MKJ | Class III | |
| K983253 | Precision A1c Home Hba1c Sample Collection Kit | Medisense, Inc. | LCP | Class II | |
| K983252 | System U3 for Gentamicin | Ab Biodisk North America, Inc. | JWY | Class II | |
| K982963 | Polymer Threaded Anchor / Suture Combination | Orthopaedic Biosystems, Ltd. | JDI | Class II | |
| K982958 | Zeta Multizone Locking Nail System | Howmedica Corp. | HSB | Class II | |
| K982759 | Auto-Lyte Cocaine Metabolite Eia, Model # 1222U | OraSure Technologies, Inc. | DIO | Class II | |
| K982188 | Steri-Pak Bowie Dick Test Pack | Steritec Products Mfg. Co., Inc. | JOJ | Class II | |
| K981975 | Latex Patient Examination Glove Powderfree (Blue Color) Polymer Coated | Siam Sempermed Corp., Ltd. | LYY | Class I |