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 |
|---|---|---|---|---|---|
| K893162 | Patient Examination Gloves | Guilin Fourth Latex Plant | LYY | Class I | |
| K893161 | Patient Examination Gloves | Shanghai Shenchang Latex Products Factory | LYY | Class I | |
| K893156 | Exam Gloves (Mfg. Suzhou Xicheng Latex Products) | China National Chemicals Import & Export (Liaoning | LYY | Class I | |
| K893137 | Excel (Tm) Chemistry Analyzer | American Monitor Corp. | JJE | Class I | |
| K893126 | Deseret(r) Introducer Set with Vitacuff(r) Device | BD Becton Dickinson Vacutainer Systems Preanalytic | LJS | Class II | |
| K892946 | Sterile Patient Examination Gloves | Yeou-Fwu Rubber Industrial Co., Ltd. | LYY | Class I | |
| K892939 | B.t.c. Patient Examination Gloves | B. Tang Chuan Co., Ltd. | LYY | Class I | |
| K892778 | Vecom Brand Patient Examination Gloves | Koolsum Ent., Inc. | LYY | Class I | |
| K892748 | Patient Exam Gloves (Mfg. Ammatex) | Dispomed, Inc. | LYY | Class I | |
| K892743 | Patient Examination Gloves (Vinyl) | Olympia & Pacific Plastics Industry Corp. | LYY | Class I | |
| K892685 | Patient Examination Gloves Dubble Butterfly | China National Chemical Construction Corp.-Qingdao | LYY | Class I | |
| K892060 | Cyberlab High Volume Drug Testing System | Syva Co. | JQP | Class I | |
| K892033 | Patient Examination Glove (Latex) | Weiss Ent., Inc. | LYY | Class I | |
| K892032 | Patient Examination Gloves (Latex) | Alizor, Inc. dba Global Tech | LYY | Class I | |
| K892013 | Patient Examination Glove (Latex) | Eastern Corp. | LYY | Class I | |
| K891822 | Patient Examination Gloves (Latex) | Kindly Assoc., Inc. | LYY | Class I | |
| K891701 | Patient Examination Gloves (Latex) | Sonley Glove Mfg., Ltd. | LYY | Class I | |
| K891635 | Patient Examination Gloves (Latex) | Lucky Medsup, Inc. | LYY | Class I | |
| K891061 | Biotrol Calcium Monoreactif | Biotrol, USA, Inc. | CJY | Class II | |
| K890817 | Omni-Trak (Patient Monitor) | Invivo Research, Inc. | CCK | Class II | |
| K890779 | Latex Examination Glove | T.K. Glove Products Co., Ltd. | LYY | Class I | |
| K890393 | Examination Gloves | Sumirubber Industries (Kedah) Sdn. Bhd. | LYY | Class I | |
| K884746 | Surgitek Flat T-Span | Medical Engineering Corp. | LCJ | Unclassified | |
| K883112 | Dermatron Skin Resistance Meter | Raymar Electronics | GZO | Class II | |
| K894602 | B1 Footswitch (Single Peddle), B2 (Double Peddle) | Beacon Laboratories, Inc. | GEI | Class II | |
| K894452 | Krr Glove, Patient Examination Gloves | Kerala Rubber & Reclaims, Ltd. | LYY | Class I | |
| K894430 | Modified Label to Percu. Intro. W/sideport & 3-Way | Daig Corp. | DYB | Class II | |
| K894353 | Orthoderm Convertible | Health Products, Inc. | IOQ | Class II | |
| K894306 | Latex Examination Gloves | Ttj Industrial Co., Ltd. | LYY | Class I | |
| K894280 | B-D Patient Examination Gloves | BD Becton Dickinson Vacutainer Systems Preanalytic | LYY | Class I | |
| K894147 | Visulin Transparent Adhesive Dressing | James River Corp. | KGX | Class I | |
| K893862 | Flexgard Syringe Protector | Dr. Gil del Castillo | FMF | Class II | |
| K893832 | CO2 Laser Systems & Arthroguide CO2 Laser Fiber | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K893785 | Arc-2F Acetabular Cup | Protek, Inc. | LWJ | Class II | |
| K893750 | Mrt-50A Mobile | Toshiba Medical Systems | LNH | Class II | |
| K893644 | Pk2025/pk2045 Programmable Video Controller | Perkins Mfg. Co. | JAA | Class II | |
| K893277 | Latex Exam Gloves (Mfg. Gloveline Industries) | China Representatives, Ltd. | LYY | Class I | |
| K893267 | Patient Examination Gloves | Hubei Provincial Medicines & Health Products Impor | LYY | Class I | |
| K892849 | Unicath a | Xre Corp. | IZI | Class II | |
| K892607 | Patient Examination Gloves (Vinyl) | Disposable Products Co. | LYZ | Class I | |
| K892565 | Patient Examination Glove (Vinyl) | Kao Ying Industrial Co., Ltd. | LYZ | Class I | |
| K892472 | Patient Examination Gloves (Latex) | Malatex Industries Sdn. Bhd. | LYY | Class I | |
| K892148 | Patient Examination Gloves (Latex) | Setia Aircon Sdn. Bhd. | LYY | Class I | |
| K892136 | Patient Examination Gloves (Latex) | Beijing Light Industrial Products Import & Export | LYY | Class I | |
| K891870 | Intrasite* Gel (3) Year Shelf Life | Smith & Nephew United, Inc. | FRO | Unclassified | |
| K891819 | Dermatec+plus(tm)& Ambiderm(tm) Latex Exam Gloves | Adler Industries, Inc. | LYY | Class I | |
| K891619 | Patient Examination Glove | Union Rubber Gloves Co., Ltd. | LYY | Class I | |
| K891499 | Patient Examination Gloves (Latex) | Promedica Sdn. Bhd. | LYY | Class I | |
| K891445 | Latex Examination Gloves | Superior Healthcare Group, Inc. | LYY | Class I | |
| K891263 | Shieldtex Patient Examination Glove (Latex) | Dah Giap Rubber Industries Sdn Bhd | LYY | Class I |