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 |
|---|---|---|---|---|---|
| K923416 | O.r. Concepts' Electrosurgical Probe | O.R. Concepts, Inc. | GEI | Class II | |
| K923199 | O.r. Concepts Electrosurgical Probes | O.R. Concepts, Inc. | GEI | Class II | |
| K922901 | Incisor I Pulsed Nd:yag Laser System | Buckman Co., Inc. | GEX | Class II | |
| K922751 | Origin Flexible Port | Origin Medsystems, Inc. | GCJ | Class II | |
| K922419 | Ipi Import | Pudenz-Schulte Medical Research Corp. | LJT | Class II | |
| K922187 | Compact Spacer | Glaxo, Inc. | CAF | Class II | |
| K922142 | Fx-Cablelok System | Bio-Tech Co. | JDQ | Class II | |
| K921216 | Off-Line Analysis System | Softheart, Inc. | DQK | Class II | |
| K925057 | Olympus Inorganic Phosphorus Reagent | Olympus Corp. | CEO | Class I | |
| K921988 | Laceration Repair Tray | Cypress Medical Products LLC | MDM | Class I | |
| K925156 | Olympus Alkaline Phosphatase Reagent | Olympus Corp. | CJE | Class II | |
| K924675 | Tsh - Third Generation Low Controls | Nichols Institute | JJX | Class I | |
| K924491 | Introducer, Percutaneous -- Modification | Greatbatch Medical | DYB | Class II | |
| K924246 | Roche Reagent for Ggt | Roche Diagnostic Systems, Inc. | JQB | Class I | |
| K923847 | Disposable Bronchoscope Biopsy Forceps | Wilson-Cook Medical Inc. | EOQ | Class II | |
| K922610 | Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K922423 | Access Surgical Bipolar Endoscopic Surg. Instrum. | Access Surgical Intl., Inc. | GEI | Class II | |
| K922231 | Olympus Cholesterol Reagent | Olympus Corp. | CHH | Class I | |
| K922176 | Intelijet Suction Supply | Smith & Nephew Dyonics, Inc. | BTA | Class II | |
| K921696 | Cutting and Coagulation Devices and Accessories | American Cyanamid Co. | GEI | Class II | |
| K911588 | Brandt Esophageal Cytology Balloon | Wilson-Cook Medical Inc. | EOX | Class II | |
| K924174 | Emerson in-Exsufflator, Models 2-Cm & 2-Ca | J. H. Emerson Co. | NHJ | Class II | |
| K924024 | Ortho Wax | Kulzer GmbH | EGD | Class I | |
| K923979 | Lc Tray Material | Dentsply Intl. | EBH | Class I | |
| K923953 | Megabeam | Ceram Optec, Inc. | GEX | Class II | |
| K923796 | Bobcat | Mobility Mfg. Co. | INI | Class II | |
| K923772 | Latex Examination Gloves | Trico Intl., Inc. | LYY | Class I | |
| K923707 | Baldur Latex Examination Gloves | Hti Trading Group | LYY | Class I | |
| K923158 | Lumico Analyzer Sa-300 | Maruzen Petrochemical Co., Ltd. | JJQ | Class I | |
| K922912 | Seeker Lite - 10 | Target Therapeutics | DQX | Class II | |
| K922425 | Access Surgical Monopolar Endoscopic Surg. Instrum | Access Surgical Intl., Inc. | GEI | Class II | |
| K922105 | Usci Linx Ez Guide Wire Exten. W/ Pro/pel Coating | C.R. Bard Inc | DQO | Class II | |
| K921978 | Breath Tracker(tm) Model 1800 Can-O-Gauge | Core-M, Inc. | CAP | Class II | |
| K921797 | Preci-Jet 50 | Hmi Industries, Inc. | KZE | Class II | |
| K921681 | Criterion, Hemocue B-Hemoglobin Control | Isolab, Inc. | GGM | Class II | |
| K924965 | Olympus Lactate Dehydrogenase Reagent | Olympus Corp. | CFJ | Class II | |
| K924863 | Aia-Pack Fsh Calibration Verification Test Set | Tosoh Medics, Inc. | JJX | Class I | |
| K924855 | Aia-Pack T-U Calibration Verification Test Set | Tosoh Medics, Inc. | JJX | Class I | |
| K924854 | Aia-Pack Pap Calibration Verification Test Set | Tosoh Medics, Inc. | JJX | Class I | |
| K924496 | Glycomat Green Hba2 Estimation Reagent Kit | Drew Scientific, Ltd. | JPD | Class II | |
| K924393 | Standard Human Plasma | Behring Diagnostics, Inc. | JPA | Class II | |
| K924350 | Hearing Aid (All-in-the-Ear) | Ear Masters, Inc. | ESD | Class I | |
| K924214 | Eclipse 2100(Tm) Model 32 | Cardiogenes | GEX | Class II | |
| K924123 | Sidestream Disposable | Medic-Aid, Ltd. | CAF | Class II | |
| K924103 | Cleaning Brush | United States Endoscopy Group, Inc. | FEB | Class II | |
| K923971 | Qc-Chex | Streck Laboratories, Inc. | JPK | Class II | |
| K923670 | Byrne Expulsive Lens | Ocular Instruments, Inc. | HJI | Class I | |
| K923619 | Acculite Ssl | Medical Alignment Systems | IWE | Class I | |
| K923572 | Vista Free Thyroxine Assay | Syva Co. | CEC | Class II | |
| K923510 | Alt (Gpt) - Alanine Aminotransferase | Randox Laboratories, Limited | CKA | Class I |