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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K892524 | Vitalograph-Breathco Monitor | Vitalograph, Inc. | CCJ | Class II | |
| K892433 | Kendall Curity Urinary Drainage Bags | The Kendal Co. | KNX | Class II | |
| K892285 | Modern (Sterile Surgeon's Gloves) | Firestone Financial Corp. | KGO | Class I | |
| K892232 | Actiderm*-Opaque | Convatec, A Division of E.R. Squibb & Sons | FRO | Unclassified | |
| K891919 | Intravascular Administration Set | Multi-Med, Inc. | FMI | Class II | |
| K891485 | Angiotec Fmx-2220 System | Andros Analyzers, Inc. | LMB | Class I | |
| K891479 | Disposable Thermoplastic Anesth Breathing Circuits | Anetec, Inc. | CAI | Class I | |
| K891375 | Iq Albumin | BD Becton Dickinson Vacutainer Systems Preanalytic | CIX | Class II | |
| K890996 | Ld1 Isoenzyme Reagent Kit | Trace Scientific, Ltd. | JGF | Class II | |
| K890823 | Accessory to Clinical Electronic Thermometer | Sheridan Catheter Corp. | FLL | Class II | |
| K890822 | Circuit Breathing (W Connector, Adapter Y Piece) | Salter Labs | BZO | Class I | |
| K890682 | Orosphere Plus | Jeneric/Pentron, Inc. | EJJ | Class II | |
| K890600 | Hydrodent Antiplaque System | Hydrodent Laboratories, Inc. | EFS | Class I | |
| K890575 | Accutherm Pts-200 | Medical Repackers Co. | DWJ | Class II | |
| K890570 | Skin Scrub Kit | Kit Pak, Inc. | LRO | Class II | |
| K890289 | Diversi-Med Sterile Latex Surgeon's Gloves | Diversi Group, Inc. | KGO | Class I | |
| K890268 | Pressure Infusor for i.v. Bags/autoinflation | Biomedical Dynamics, Inc. | KPE | Class II | |
| K890035 | Bacteria Filter | Hudson Oxygen Therapy Sales Co. | CAH | Class II | |
| K885031 | Low Adsorption Administration Set | 3M Company | FPA | Class II | |
| K884564 | Shiley Therapeutic Autotransfusion System-Programm | Shiley, Inc. | CAC | Class II | |
| K884107 | Stereotactic Biopsy Attachment | Siemens Medical Solutions USA, Inc. | IZH | Class II | |
| K892667 | Saf-T-Shunt Silicone Rubber U, Prod. Code S-313 | Akcess Medical Products, Inc. | FKN | Class II | |
| K892666 | Saf-T-Shunt, S-300 Series | Akcess Medical Products, Inc. | FIQ | Class II | |
| K892663 | S-100 Allen-Brown Shunt | Akcess Medical Products, Inc. | FIQ | Class II | |
| K892409 | Quidel Food Allergen Screen - Barley Allergen | Ortho-Clinical Diagnostics, Inc. | DHB | Class II | |
| K892384 | Biliary Endoprosthesis and External Catheter | Porges Corp. | FGE | Class II | |
| K892383 | Biliary Endoprosthesis for Internal Drainage Set | Porges Corp. | FGE | Class II | |
| K892223 | Behring Nephelometer 100 | Behring Diagnostics, Inc. | JZW | Class I | |
| K892109 | Patient Examination Gloves (Latex) | Brilliant Ray Intl., Inc. | LYY | Class I | |
| K892086 | Patient Examination Gloves (Latex) | Cypress Medical Products LLC | LYY | Class I | |
| K891851 | Patient Examination Gloves (Latex) | Klh Medical, Inc. | LYY | Class I | |
| K891777 | Pro-Cut Biopsy Needle | Teknar, Inc. | FCG | Class II | |
| K891696 | Duoderm* Extra Thin Flexible Hydrocolloid Dressing | Convatec, A Division of E.R. Squibb & Sons | NAD | Class I | |
| K891427 | Patient Examination Gloves (Latex) | Shinheng Corp. | LYY | Class I | |
| K891313 | Patient Examination Gloves | Dr. Boo Co., Ltd. | LYY | Class I | |
| K891274 | Patient Examination Glove (Latex) | Yue Chuen Co., Ltd. | LYY | Class I | |
| K891194 | Patient Examination Gloves | Star Light Ent. Corp. | LYY | Class I | |
| K891127 | Patient Examination Glove (Latex) | Sppik Rubber Industries Sdn. Bhd. | LYY | Class I | |
| K891012 | Patient Examination Gloves | Semodal Jaya Sdn. Bhd. | LYY | Class I | |
| K890967 | Vinyl Examination Gloves (Mfg. Salzgitter Morex) | Amerimed US Corp. | LYZ | Class I | |
| K890872 | Patient Examination Gloves | Unigloves, Ltd. | LYY | Class I | |
| K890818 | Auto Suture Disposable Surgical Trocar* | United States Surgical, A Division of Tyco Healthc | FZT | Class I | |
| K890622 | Surg-E-Trol System I and System II | Mentor O & O, Inc. | HQE | Class II | |
| K884791 | Perme-Aid Transparent Dressing, #11Xx | Nitto Denko Technical Corp. | NAD | Class I | |
| K884267 | Electrode A.ph Blood Gas B.electrolyte Systems | Alko Diagnostic Corp. | CHL | Class II | |
| K883641 | Selective Rapid Urea | Remel Inc | LYR | Class I | |
| K891217 | Iq Calcium | BD Becton Dickinson Vacutainer Systems Preanalytic | CIC | Class II | |
| K891167 | Coat-a-Count(tm) Lsd Radioimmunoassay Kit | Siemens Healthcare Diagnostics Inc. | DLB | Class II | |
| K891143 | General Electric Amx 110 | Pro-Tronics, Inc. | IZL | Class II | |
| K890792 | Potassium and Sodium Electrolyte Analyzer | Ionetics, Inc. | CEM | Class II |