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 |
|---|---|---|---|---|---|
| K893144 | Latex Exam Gloves (Mfg. Guangzhou No. 11 Rubber) | Guangzhou Chemicals Import & Export Corp. | LYY | Class I | |
| K893143 | Latex Exam Gloves (Mfg. Guangdong Zhongshan) | Guangzhou Chemicals Import & Export Corp. | LYY | Class I | |
| K893076 | Proson Patient Examination Gloves | Long Far Industry Co., Ltd. | LYY | Class I | |
| K892980 | Longfortune Patient Exam Gloves | Long Fortune Industries, Ltd. | LYY | Class I | |
| K891809 | Patient Examination Gloves (Latex) | Firestone Financial Corp. | LYY | Class I | |
| K891808 | Patient Examination Gloves (Latex) | Anro Corp. Sdn Bhd | LYY | Class I | |
| K891804 | Hygeia Examination Gloves | Rubtex, Ltd. | LYY | Class I | |
| K891787 | Patient Examination Gloves (Latex) | Socoil Latex Products Sdn Bhd | LYY | Class I | |
| K891747 | Patient Examination Gloves (Latex) | Arden Sales, Inc. | LYY | Class I | |
| K891668 | Patient Examination Gloves (Latex) | Influx Pacific Sdn. Bhd. | LYY | Class I | |
| K891665 | Patient Examination Gloves (Latex) | Clinical Supply | LYY | Class I | |
| K891629 | Patient Examination Gloves (Latex) | Union Rubber Gloves Co., Ltd. | LYY | Class I | |
| K891497 | Patient Exam Gloves (Latex) Mfg. Hua Guang | B.C. Young Intertrade Corp. | LYY | Class I | |
| K891496 | Patient Exam Gloves (Latex) Mfg. China Xinxing | B.C. Young Intertrade Corp. | LYY | Class I | |
| K891495 | Patient Examination Gloves (Latex) | Salcon Rubber Sdn Bhd | LYY | Class I | |
| K891494 | Esserel Patient Examination Gloves (Latex) | Karthik Engineering, Inc. | LYY | Class I | |
| K891340 | Patient Examination Gloves (Latex) | Partech Co., Inc. | LYY | Class I | |
| K891285 | Patient Examination Gloves (Latex) | Buildvest Holdings Sdn Bhd | LYY | Class I | |
| K890968 | Vinyl Examination Gloves (Mfg. Salzgitter Morex) | Interpro Intl., Inc. | LYZ | Class I | |
| K890275 | Acuson S328 Transducer for Fetal Cardiac Pulsed | Acuson Corp. | IYO | Class II | |
| K883804 | E-Mitt (Conductive Hand Cover) | The Institute for Technology Development | EAT | Class II | |
| K873295 | Prostatic Urethro. Balloon Dilatation Catheter | Medi-Tech, Inc. | KOE | Class II | |
| K894344 | Electro-Lite Power Wheelchair | Damaco | ITI | Class II | |
| K894253 | Quidel Food Allergen Screen | Ortho-Clinical Diagnostics, Inc. | DHB | Class II | |
| K894195 | Latex Examination Gloves | Jiahn Chiaur Enterprise Co., Ltd. | LYY | Class I | |
| K893825 | Latex Examination Gloves | Frank W. Winne & Son, Inc. | LYY | Class I | |
| K893756 | Surgicare (R) Specialty Examination Gloves | Inter Continental Health Care | LYY | Class I | |
| K893621 | Concoa Pressure Regulators | Concoa Controls Corp. of America | CAN | Class I | |
| K893584 | Gripper II Acetabular Cup | Joint Medical Products Corp. | LWJ | Class II | |
| K893487 | Lifecare 75 Controller | Abbott Medical | LDR | Class II | |
| K893485 | Accelograph Neuromuscular Transmission Monitor | Biometer Intl. A/S | BXN | Class II | |
| K893440 | Flex Sigmoidoscope Light Source Model #45150 | Welch Allyn Inc | FFS | Class II | |
| K893252 | Whiteside Ortholoc M.a. Total Knee System | Dow Corning Wright | JWH | Class II | |
| K893057 | Medi, Ultra, Curi Exam Gloves | Sinjaca Inc. dba Sic Medical & Surgical Supplies | LYY | Class I | |
| K892707 | Dvm-4200 Blood Flowmeter | Koven and Assoc., Inc. | DPW | Class II | |
| K892606 | Patient Examination Gloves (Latex) | Tritech Mfg. Industries, Inc. | LYY | Class I | |
| K892489 | Patient Exam Gloves (Mfg. United Lion Rubber) | Chori America, Inc. | LYY | Class I | |
| K892461 | Non-Sterile Latex Examination Gloves | Rahn Laboratories | LYY | Class I | |
| K892016 | Patient Examination Gloves (Latex) | Winhace Trading, Inc. | LYY | Class I | |
| K891862 | Patient Exam Gloves (Mfg. Hebei Xinji & Xinji Wen) | China Xinxing Corp., Ltd. | LYY | Class I | |
| K891861 | Patient Exam Gloves (Mfg. Tianjin & Jingjin) | China Xinxing Corp., Ltd. | LYY | Class I | |
| K891505 | Patient Examination Gloves (Latex) | Taiwan Link Sdn Bhd | LYY | Class I | |
| K891275 | Patient Examination Gloves (Latex) | M.R. Rubber Industries Sdn. Bhd. | LYY | Class I | |
| K891246 | Patient Examination Gloves (Latex) | Penfirst Corp. Sdn. Bhd. | LYY | Class I | |
| K890786 | Ivsk09 Calibration Kit an Accessory to Iv7000/7200 | Medtronic, Inc. | FRN | Class II | |
| K894393 | Opmilas CO2-L | Carl Zeiss, Inc. | GEX | Class II | |
| K894345 | Enabler Lightweight Manual Wheelchair | Damaco | IOR | Class I | |
| K894140 | Medtronic Model 9443 in-Office Transmitter | Medtronic, Inc. | DXH | Class II | |
| K894052 | Electra 1000C Automatic Coagulation Timer | Medical Laboratory Automation Systems, Inc. | GKP | Class II | |
| K893894 | Charise Charles Reagent Blood Strips | Lee Import Domestic Consulting | JIO | Class II |