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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K861607 | Schneider-Shiley Inflation Syringes | Shiley, Inc. | MAV | Class II | |
| K861606 | Schneider-Shiley Wire Torquer | Shiley, Inc. | DQX | Class II | |
| K861510 | Multilumen Viapic Central Line Catheter | Warner-Lambert Co. | FOZ | Class II | |
| K861436 | Sof Set, Models 111 and 112 | Pacesetter Systems | FRN | Class II | |
| K861324 | Patientcare 1000 | Criticare Technologies, Inc. | FRN | Class II | |
| K861306 | Suction System | Axiom Medical, Inc. | GEA | Class I | |
| K861162 | Lens Spectacle Non-Custom (Prescription) | Efop | HQG | Class I | |
| K860222 | 70 Ml Reservoir Bag and Administration Sets | Prn Services, Inc. | FRN | Class II | |
| K854481 | Colin Electronics Co., Ltd. Stbp 680 | Colin Medical Instruments Corp. | DXN | Class II | |
| K854193 | Electro-Myographic Perineometer | Verimed Holdings, Inc. | HIR | Class II | |
| K853561 | Lifestat 100 | Physio Control, Inc. | DXN | Class II | |
| K861954 | Hexagonal Wrenches | Med-Tool, Inc. | |||
| K861953 | Parallel Action Pliers | Med-Tool, Inc. | HTC | Class I | |
| K861952 | Compound Leverage Snip | Med-Tool, Inc. | |||
| K861947 | Surgical Knife | Sharpoint, Inc. | EMF | Class I | |
| K861937 | Aquacel Surgical Prep Pads | Advanced Ortho-Technology, Inc. | |||
| K861924 | Micro Anastomosis Clamp | Pilling Co. | DXC | Class II | |
| K861919 | Ventrex Apo B | Ventrex Laboratories, Inc. | MSJ | Class I | |
| K861914 | Treace Medical Foam Instrument Pad | Treace Medical, Inc. | |||
| K861757 | 5 in 1 Connector | Jackson Plastics, Inc. | GAZ | Class II | |
| K861481 | Endocardial Carbon-Tip Lead | Pacesetter Systems | DTB | Class III | |
| K861471 | V. Mueller Vital Clip-Hemostatic Clip | American V. Mueller | FZP | Class II | |
| K861362 | Immunomedics Serum Elisa Test System | Immunomedics, Inc. | CZW | Class II | |
| K860914 | Isolated Solid-State Relay Multiplexer & F/f Conv | Bio-Feedback Systems, Inc. | GWK | Class II | |
| K860584 | Software Module/2035 Prog and Astra/t Pulse Gen | Cardiac Pacemakers, Inc. | KRG | Class III | |
| K862084 | E. T. Tape Endotracheal Tube Holder | B & B Medical Technologies, Inc. | CBH | Class I | |
| K862066 | Titertek Microplate Washer S-12 | Flow Laboratories, Inc. | JTC | Class I | |
| K862042 | Sh20, Sh30 & Sh50 Ultrasonic Humidifier | Associated Mills, Inc. | KFZ | Class I | |
| K861893 | Ggt Reagent Cartridge (Product No. 88204) | Hi Chem, Inc. | JXL | Class II | |
| K861665 | Creatine Phrosphokinase (Ck) Procedure | Data Medical Associates, Inc. | CGS | Class II | |
| K861555 | Circapak Universal Volume Ventilator Circuit | Respiratory Care, Inc. | BZD | Class II | |
| K861532 | Rx-33S Intra Mini Canal Module | Rexton, Inc. | ESD | Class I | |
| K861227 | Collins Pneumotach Pft System | Warren E. Collins, Inc. | BZG | Class II | |
| K861067 | Paragon 420, Cardiac Monitor | Life Sensing Instrument Company, Inc. | DPS | Class II | |
| K860903 | Tm-3600 a Neurodiagnostic System | Tracor Northern, Inc. | GWF | Class II | |
| K860901 | Laser Resistant Tracheal Tube (Tentative) | Mallinckrodt Critical Care | BTR | Class II | |
| K860164 | 2500 Printer | Datascope Corp. | |||
| K860051 | Model 8604 Oxygen/pulse Monitor | Nonin Medical, Inc | DQA | Class II | |
| K854769 | Lni Mgv Medical Gas Mixer | P.A. Mccauley, Inc. | BZR | Class II | |
| K854665 | 4312P Polysomnograph Electoenciphalograph | Nihon Kohden America Inc | OLV | Class II | |
| K854647 | Polo Dental Unit | Alpine Dental Equipment Co. | KLC | Class I | |
| K862016 | Pach-Pen Surgical Drape | Oculab, Inc. | KKX | Class II | |
| K861969 | Sterile Towel W/antimicrobial Agent | DeRoyal Industries, Inc. | KKX | Class II | |
| K861881 | Rubalex (Revised Version) | Orion Corp. | LQN | Class II | |
| K861558 | Aplicare Skin Protectant Swabstick | Aplicare, Inc. | NEC | Class I | |
| K861182 | Timeline Venipuncture System | Ipax, Inc. | FPA | Class II | |
| K860609 | Timeline Venipuncture System | Ipax, Inc. | FPA | Class II | |
| K854687 | Erma Hb-Meter Model 303N | Future Impex Corp. | KHG | Class II | |
| K854686 | Te-25 Coaguro Meter | Future Impex Corp. | JBP | Class II | |
| K861890 | 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2 | Richard-Allan Medical Ind., Inc. | PPM | Class I |