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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K811381 | Astra | Chem-Elec, Inc. | JFL | Class II | |
| K811376 | Ultrasonic Qfm System 1000 | Narco Bio-Systems | DPW | Class II | |
| K811319 | Chloride Reagent Kit | Chem-Elec, Inc. | JFS | Class II | |
| K811200 | Pacepath Implantable Endocard. Pacing Ld | Pacesetter Systems | DTB | Class III | |
| K811165 | Glucose Oxidase Rate Reagent | Chem-Elec, Inc. | CGA | Class II | |
| K811083 | Esophageal Motility Probe | Konigsberg Instruments, Inc. | FFT | Class I | |
| K812100 | Seralyzer | Miles Laboratories, Inc. | CHH | Class I | |
| K812091 | Fast Choles-Cinet | Sclavo, Inc. | CHH | Class I | |
| K812081 | Wako Nefa C Test | FUJIFILM Healthcare Americas Corporation | JLG | Class I | |
| K812076 | Anti-Gm & Anti-Km Typing Serums | Biotest-Serum-Institut | DGH | Class II | |
| K812075 | Nichole's 99 | Healthcare Ind. | CAH | Class II | |
| K812067 | Inspiratory Force Pressure Adaptor | Airlife, Inc. | BZA | Class I | |
| K812056 | Spectro Feiritin | Ramco Laboratories, Inc. | DBF | Class II | |
| K812054 | Endab Digoxin Kit | IMMUNOTECH s.r.o. | KXT | Class II | |
| K812031 | Lpc II | Labtronix Corp. | GKL | Class II | |
| K811991 | Simvac | The Lynn Terrell Co. | CBO | Class II | |
| K811978 | Technicon H6000 (90/Hr) Hematology Sys | Technicon Instruments Corp. | GKL | Class II | |
| K811872 | Teflon Pledget Suture Buttress | Ethicon, Inc | DXZ | Class II | |
| K811828 | Sickle Cell Reagent Set | Anco Medical Reagents & Assoc. | GHM | Class II | |
| K811800 | Bluing Reagent | Richard-Allan Medical Ind., Inc. | PPM | Class I | |
| K811613 | 72 Determin. Size Radial Immunod. Test | Kent Laboratories, Inc. | DDG | Class II | |
| K811595 | Sp-100-B Small Parts Scanner System | Highstoy | DXK | Class II | |
| K811416 | Moore Hip Prosthesis, Pmma Coated | Zimmer GmbH | KWL | Class II | |
| K811261 | Anti-Skin Antibody Test System | Zeus Scientific LLC | DBL | Class II | |
| K811246 | Doppler Ultrasound Blood Flowmeter | Irex Corp. | DPW | Class II | |
| K810414 | Usci Doppler Catheter System | C.R. Bard Inc | JOP | Class II | |
| K811807 | Uroskop C | Siemens Corp. | KPR | Class II | |
| K811627 | Arrow Peritoneal Lavage Catherization K | Arrow Intl., Inc. | GBW | Class I | |
| K811572 | Atl's Mark 100/300 Ultrasound Systems | Advanced Technology Laboratories, Inc. | IYO | Class II | |
| K812047 | Ids Beta-Lactamase Disc | Carr-Scarborough Microbiologicals, Inc. | JTO | Class I | |
| K812046 | Tidal Volume Monitor 150 | Medix Medical Electronics (U.S.A.), Inc. | BZK | Class II | |
| K812036 | Neurogar III | Inter Med Industries, Inc. | GZJ | Class II | |
| K811960 | Visitec Neddle Tange (Surgery) | Visitec Co. | |||
| K811938 | Adaptaid Lead Adapter #365-25 | Intermedics, Inc. | DTD | Class II | |
| K811859 | Bactashield | Tri-Med, Inc. | FIB | Class II | |
| K811769 | Laparotomy Pads | South Mountain Medical | GDY | Class I | |
| K811577 | Crouch Corneal Protector | Denver Biomedicals, Inc. | HOY | Class I | |
| K811389 | Playtex Cotton Tampons | Playtex, Inc. | HIL | Class II | |
| K811388 | Playtex Cotton Digital Tampon | Playtex, Inc. | HEB | Class II | |
| K811387 | Playtex Combination Fiber Modified Tamp | Playtex, Inc. | HIL | Class II | |
| K811385 | Playtex Digital Tampon | Playtex, Inc. | HEB | Class II | |
| K811252 | Ms-50 Ultrasonic Imager | Kontron Instruments, Inc. | IYO | Class II | |
| K810494 | Type Fh Endocardial Lead | Biotronik Sales, Inc. | DTB | Class III | |
| K812079 | Disposable Pillow | Carpenter Co. | KME | Class I | |
| K812044 | Respiration Rate Monitor 120/121 | Medix Medical Electronics (U.S.A.), Inc. | BZQ | Class II | |
| K811981 | Isolater Thp | Tri-Med, Inc. | KOC | Class II | |
| K811955 | Calibrated Breathing System Collection | Anchor Brush Co., Inc. | KDQ | Class II | |
| K811819 | Boundary Sterilization Wrap | The Buckeye Cellulose Corp. | FRG | Class II | |
| K812080 | Aegis i.v. Strips | Warner-Lambert Co. | KMK | Class I | |
| K812066 | Percento Mask, Pediatric, Under-the-Chin | Airlife, Inc. | BYF | Class I |