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 |
|---|---|---|---|---|---|
| K904298 | Euro-Diagnostic Blood Pressure Monitor | Medi-Swiss Corp. | DXN | Class II | |
| K904239 | Soft Hydroxylapatite Ossicular Malleable Prosthes | Microbio-Medics, Inc. | ETA | Class II | |
| K903013 | Lyme Igm Elisa Test | Gull Laboratories, Inc. | LSR | Class II | |
| K912601 | Biprobe(tm) | C.R. Bard Inc | KNS | Class II | |
| K912324 | Neonatal Tsh (125I) Immunoradiometric Assay | BD Becton Dickinson Vacutainer Systems Preanalytic | JLW | Class II | |
| K912241 | Stratus(r) Htsh Fluormetric Enzyme Immunoassay | Baxter Healthcare Corporation | JLW | Class II | |
| K912204 | Telex Model Tlp, in-the-Ear | Telex Communications, Inc. | ESD | Class I | |
| K911892 | Rx-5000 MRI System | Resonex, Inc. | LNH | Class II | |
| K911796 | Immulite(tm) Hcg | Cirrus Diagnostics, Inc. | DHA | Class II | |
| K911635 | Meadox(r) Surgimed(r) Biopsy Gun II | Meadox Surgimed, Inc. | KNW | Class II | |
| K911480 | Flexible Choledochoscope | United States Endoscopy Group, Inc. | FBN | Class II | |
| K911453 | Obtrasound Stethoscope Fetal Calc | Medasonics, Inc. | KNG | Class II | |
| K911274 | Unipolar Coagulator Probe System | American Surgical Instruments Corp. | GEI | Class II | |
| K911262 | Disposable Specimen Bag W/cannula and Introducer | Ethicon, Inc | GEA | Class I | |
| K910963 | Thorocentesis Kit | Megadyne Medical Products, Inc | JOL | Class II | |
| K910734 | Medisystems Hemodialysis Fistula Set | Medisystems Corp. | FIE | Class II | |
| K910580 | Microstim 100 Model 2C | Microstim, Inc. | GZJ | Class II | |
| K910089 | Mega Lumbar Puncture Kit | Megadyne Medical Products, Inc | FMJ | Class II | |
| K905575 | Modified Models 2000W and 2000W Option H Apnea Mon | Edentec Corp. | BZQ | Class II | |
| K912469 | Bivona Wire Reinforced Pediatric Tracheostomy Tube | Bivona Medical Technologies | BTO | Class II | |
| K911695 | Various X-Ray Tubes | Comet Ltd. C/O Radiology Resources, Inc. | ITY | Class I | |
| K911243 | Cholangiocath and Atraumatic Bowel Clamp | Northgate Technologies Inc. | GCJ | Class II | |
| K910990 | Osteonics 7000 Series Total Knee Tibial Components | Osteonics Corp. | JWH | Class II | |
| K910247 | Zodiac 901 Middle-Ear Analyzer | Madsen Electronics (Canada), Ltd. | ETY | Class II | |
| K910238 | Portable Auto Transfusion System 500 | Electromedics, Inc. | CAC | Class II | |
| K905573 | Xemex Enteral Nutrition Catheter Nasogas. Type a | Zeon Medical Corp. | BSS | Class II | |
| K905563 | Intran Plus | Utah Medical Products, Inc | KXO | Class II | |
| K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat II | Kontron Instruments, Inc. | DSP | Class II | |
| K905154 | Gastroscan | Medics Instrument Corp. | FFX | Class II | |
| K904863 | Mga-Ir Sidestream Pco2 Module | Marquette Gas Analysis Corp. | CCK | Class II | |
| K903966 | External Pacemaker Analyzer Model PMA-1 | Bio-Tek Instruments, Inc. | DTC | Class II | |
| K912343 | Distendable Palpation Probe | Dexide, Inc. | GCJ | Class II | |
| K912031 | Avi Model 870 Dual Channel Infusion Pump | 3M Avi, Inc. | FRN | Class II | |
| K911931 | Luer Lock Injection Cap | Dmd Products | FPA | Class II | |
| K911839 | Neonatal Blood Spot Test 17-Hydroxprog Radio Kit | Pantex, Div. Bio-Analysis, Inc. | JLX | Class I | |
| K911757 | Maxibond | Argen Precious Metals, Inc. | EJS | Class II | |
| K911670 | Cerapall | Metalor Dental USA Corp. | EJS | Class II | |
| K911471 | Lung Diffusion Gas Mixtures | Norco, Inc. | BXK | Class I | |
| K911450 | Infant Ventilator | Preemicare Corp. | CBK | Class II | |
| K911344 | Cerion Hand Held Oxygen Analyzer | Ceramatec, Inc. | CCL | Class II | |
| K911236 | Medtronic Permanent Lead Introducer, Various Mdls | Medtronic, Inc. | DYB | Class II | |
| K911153 | Microzyme Phencyclidine Enzyme Immunoassay Test Kt | IMMUNOTECH s.r.o. | LCM | Unclassified | |
| K911110 | Ophta Sil(r), Enulceation/evisceration Implants | G.W.B. Intl., Ltd. | HPZ | Class II | |
| K910856 | Manual Resuscitator | Vital Signs, Inc. | BTM | Class II | |
| K910699 | Life-02 (Non-Refillable Cylinder) | Life Corp. | BTL | Class II | |
| K910128 | Levtech Titanium Bone Wire | Levtech, Inc. | JDQ | Class II | |
| K905383 | 2710-000 Oscillating Saw, General Assembly | Micro Surgical Instruments Corp. | GEY | Class I | |
| K904631 | Centauri Yag Laser Syst, Neurosurgery | Pfizer Laser Systems | GEX | Class II | |
| K904328 | Vista Polysomnography Computer System | Telediagnostic Systems, Inc. | GWK | Class II | |
| K912379 | Pdt Carryall Transmitter, Various Models | Cardiac Pacemakers, Inc. | DXH | Class II |