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 |
|---|---|---|---|---|---|
| K961573 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | CIN | Class II | |
| K961374 | Philips Multidiagnost 4 | Philips North America LLC | OWB | Class II | |
| K960962 | Interference Screw | Linvatec Corporation | HWC | Class II | |
| K960861 | Omicron Monitor, Delta Monitor | Core-M, Inc. | CBK | Class II | |
| K951113 | Cross-Checks | Steritec Products Mfg. Co., Inc. | LRT | Class II | |
| K963002 | Active Androstenedione Eia | Diagnostic Systems Laboratories, Inc. | CIZ | Class I | |
| K962809 | Seirin Acupuncture Needles | Seirin-America, Inc. | MQX | Class II | |
| K962762 | Sequential Sample Multi-Photon Detector | Biotraces, Inc. | JJJ | Class I | |
| K962280 | Abuscreen Online Positive Control / 1.5X Calibrator | Roche Diagnostic Systems, Inc. | DLJ | Class II | |
| K962150 | Dried Gram-Negative and Gram-Positive Mic/combo Panels | Dade Intl., Inc. | LTT | Class II | |
| K961976 | The Bioplate Fixation System | Biomedics | JEY | Class II | |
| K961896 | Microlab 4000, Microlab 4200 | Hamilton Co | JQW | Class I | |
| K961837 | Rush Oral/nasal Tracheal Tube Cuffed Magill/murphy | Rusch Intl. | BTR | Class II | |
| K961357 | Pro-Flex, Digital Thermometer with Flexible Probe | Intelligent Product Limited Co. | FLL | Class II | |
| K961281 | Triglyceride-Sl Assay Catalogue No. 236-60 | Sekisui Diagnostics P.E.I. Inc. | CDT | Class I | |
| K960790 | Prospore II | Raven Biological Laboratories, Inc. | FRC | Class II | |
| K960437 | Radias Phenylalanine Test | Bio-Rad | JNB | Class II | |
| K955546 | Patient Monitor Model 405P | Ivy Biomedical Systems, Inc. | DPS | Class II | |
| K955107 | Safestrip | Firehouse Medical, Inc. | CGA | Class II | |
| K954575 | Axsym Toxo Igg Antibody Assay | Abbott Medical | LGD | Class II | |
| K962997 | Nova Chemistry Controls with Creatinine, Levels (1, 2) and 3 | Nova Biomedical Corporation | JJY | Class I | |
| K962841 | Opus Myoglobin Controls | Behring Diagnostics, Inc. | JJX | Class I | |
| K962673 | Accusign Mtd-Rapid One-Step Methadone Assay | Princeton BioMeditech Corp. | DJR | Class II | |
| K962669 | Accusign Bar-Rapid One-Step Barbiturate Assay | Princeton BioMeditech Corp. | DIS | Class II | |
| K962650 | Patient Latex Examination Gloves (Powdered, Non Sterile) | Sti Medical Sdn Bhd | LYY | Class I | |
| K962602 | Aca Plus Free Thyroxine(ft4) Method | Dade Intl., Inc. | CEC | Class II | |
| K962594 | Aca Plus Ft4 Calibrator | Dade Intl., Inc. | JIT | Class II | |
| K962508 | Elecsys T3 | Boehringer Mannheim Corp. | CDP | Class II | |
| K962344 | Myoglobin Assay for the Technicon Immuno 1 System (in-Vitro Diagnostic System) | Bayer Corp. | DDR | Class II | |
| K962247 | Hichem Ck/nac Reagent Kit | Elan Pharma, Inc. | CGS | Class II | |
| K962240 | Moore Tracheostomy Tube | Boston Medical Products, Inc. | BTO | Class II | |
| K962215 | Consensus Posterior Stabilized Knee-Intercondylar Notch Router | U.S. Medical Products, Inc. | HWE | Class I | |
| K962161 | Baxter Nebulizer Cap Model 2D0868 | Baxter Healthcare Corporation | CAF | Class II | |
| K962023 | Plastic Protection Healing Caps | Straumann USA, LLC | DZE | Class II | |
| K961973 | Dhd Ace with Mask Kit | Dhd Diemolding Healthcare Div. | CAF | Class II | |
| K961936 | Model 2188 Coronary Sinus Lead. | Medtronic, Inc. | DTB | Class III | |
| K961923 | Berenstein Coil | Target Therapeutics | HCG | Class II | |
| K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | BZD | Class II | |
| K961912 | Qualitrol, (Alfa Fetoprotein) Afp Control Set | Consolidated Technologies, Inc. | JJY | Class I | |
| K961682 | Argon Curing Laser | Premier Laser Systems, Inc. | GEX | Class II | |
| K961365 | Endocare Electornic Thermometer System | Varian Medical Systems, Inc. | FLL | Class II | |
| K960940 | Bioscrew Absorbable Interference Screw | Linvatec Corporation | HWC | Class II | |
| K960841 | Powder-Free Latex Exam Glove W/hypoallergenic Claim | Boston Medical Corp. | LYY | Class I | |
| K960584 | Novanew Reconditioning System for Prof. Use in-Office Use Only | Novavision, Inc. | HQD | Class II | |
| K955507 | Grayco Pocket Pump | Grayco, Inc. | BTM | Class II | |
| K955113 | Dinamap Select Multi-Parameter System | Johnson & Johnson MEDICAL GmbH | DPS | Class II | |
| K954995 | Quix Rapid Cholera Strip Test | Guardian Scientific, Corp. | GSQ | Class II | |
| K954736 | Access (Powerclave) | Mdt Biologic Co. | FLE | Class II | |
| K951033 | Andela Dynamic Cooling Device | Candela Corporation | IMD | Class I | |
| K962789 | Surgical Kit-Acufex Mosaicplasty System | Smith & Nephew Endoscopy, Inc. | GEY | Class I |