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 |
|---|---|---|---|---|---|
| K892498 | Patient Examination Gloves (Latex) | Yi Feng Industrial Co., Ltd. | LYY | Class I | |
| K892497 | Patient Examination Gloves (Latex) | Ching Feng Blinds Co., Ltd. | LYY | Class I | |
| K892496 | Patient Examination Gloves (Latex) | Easter on Right Industrial Co. | LYY | Class I | |
| K892490 | Patient Exam Gloves (Mfg. Tomarc) | Chori America, Inc. | LYY | Class I | |
| K892487 | Patient Examination Gloves | Allied Rubber Industries Sdn. Bhd. | LYY | Class I | |
| K892470 | Patient Examination Gloves (Latex) | Moore Medical Corp. | LYY | Class I | |
| K892468 | Patient Examination Gloves (Latex) | Hwa Shun Rubber Ent. Co., Ltd. | LYY | Class I | |
| K892465 | Non-Sterile Patient Examination Gloves | Crocker Industrial Resources Sdn. Bhd. | LYY | Class I | |
| K892463 | Patient Examination Gloves (Latex) | Civilized Lawana Co., Ltd. | LYY | Class I | |
| K892446 | Shiley Equipment Support Carts Esc-002 & Escb-02 | Shiley, Inc. | KRD | Class II | |
| K892436 | Kendall Curity Irrigation Syringe | The Kendal Co. | KOD | Class II | |
| K892430 | Disposable Disc Filter | The Medi-Dose Group | FMF | Class II | |
| K892428 | Combi-Cap | The Medi-Dose Group | FMF | Class II | |
| K892352 | Patient Examination Gloves (Latex) | Norsechem Latex Products (M) Sdn Bhd | LYY | Class I | |
| K892326 | Latex Examination Gloves | Safety Supply House of Louisiana, Inc. | LYY | Class I | |
| K892320 | Patient Exam Gloves (Latex) | Wood Ting Industry Co. C/O Lowenkamp Intl. | LYY | Class I | |
| K892295 | Sevacare Patient Examination Gloves | Sevaids Industries | LYY | Class I | |
| K892294 | Patient Examination Gloves (Latex) | Ardil Surgical Co. Pvt., Ltd. | LYY | Class I | |
| K892274 | Patient Examination Gloves (Latex) | Beta Chemicals, Inc. | LYY | Class I | |
| K892273 | Patient Examination Gloves (Latex) | Rouge Ent., Inc. | LYY | Class I | |
| K892271 | Patient Examination Gloves (Latex) | Asma Rubber Products Pvt., Ltd. | LYY | Class I | |
| K892270 | Patient Examination Gloves (Latex) | Global Latex Products Sdn Bhd | LYY | Class I | |
| K892267 | Patient Examination Gloves (Latex) | Ejs Sdn. Bhd. | LYY | Class I | |
| K892240 | Patient Examination Gloves (Latex) | Unitex Rubber Industry Co., Ltd. | LYY | Class I | |
| K892169 | Patient Examination Gloves (Latex) | Hands-On Packaging, Ltd. | LYY | Class I | |
| K892168 | Latex Exam Gloves (Surgical Type Glove) | Hands-On Packaging, Ltd. | LYY | Class I | |
| K892166 | Non-Sterile Patient Exam Gloves (Latex) | Ergo Intl., Ent., Inc. | LYY | Class I | |
| K892159 | Patient Exam Gloves (Mfg Chaoyang Synthetic Fibre) | Sinochem (USA), Inc. | LYY | Class I | |
| K892158 | Patient Exam Gloves (Mfg. Suzhou Latex Factory) | Sinochem (USA), Inc. | LYY | Class I | |
| K892157 | Patient Exam Gloves (Mfg. Rongcheng Latex Product) | Sinochem (USA), Inc. | LYY | Class I | |
| K892156 | Patient Exam Gloves (Mfg. No. 1 Factory, Wuhan) | Sinochem (USA), Inc. | LYY | Class I | |
| K892155 | Patient Exam Gloves (Mfg. Hubei Tianmen Latex) | Sinochem (USA), Inc. | LYY | Class I | |
| K892154 | Patient Exam Gloves (Mfg. Liaoning Foreign Trade) | Sinochem (USA), Inc. | LYY | Class I | |
| K892153 | Patient Exam Gloves (Mfg. Jiande Rubber Products) | Sinochem (USA), Inc. | LYY | Class I | |
| K892151 | Patient Exam Gloves (Mfg. Guilin Latex Factory) | Sinochem (USA), Inc. | LYY | Class I | |
| K892131 | Patient Examination Gloves (Latex) | Five Lakes Co., Inc. | LYY | Class I | |
| K892123 | Goettinger Emergency Resuscitation Tube | Plastic Parts Corp. | CAE | Class I | |
| K892122 | Patient Examination Gloves (Latex) | Wallgear Industrial Ltd. C/O Condor Financial | LYY | Class I | |
| K892097 | Champ-Paq Latex Patient Exam Gloves | Winmed Instruments Mfg. Corp. | LYY | Class I | |
| K892089 | Patient Examination Gloves (Latex) | N.V. Kalibaru | LYY | Class I | |
| K892075 | Medline Latex Exam Gloves | MEDLINE INDUSTRIES, LP - Northfield | LYY | Class I | |
| K892029 | Patient Examination Gloves (Latex) | Votra (Malaysia) Sdn Bhd | LYY | Class I | |
| K892015 | Patient Examination Gloves (Latex) | China North Industries Corp. | LYY | Class I | |
| K892014 | Patient Examination Glove (Latex) | Dipform Rubber Sdn. Bhd. | LYY | Class I | |
| K891982 | J1 Attachment (Orthodontic Appliance) | T.M.K. Dental Products | EJF | Class I | |
| K891967 | Patient Examination Gloves (Natural Latex) | Butex Products (M'Sia) Sdn.Bhd | LYY | Class I | |
| K891966 | Alamtex Patient Examination Gloves (Latex) | Concept Rubber Products Sdn Bhd | LYY | Class I | |
| K891963 | Nic Brand Patient Examination Gloves | Nikemark Tape Industrial Corp. | LYY | Class I | |
| K891957 | Patient Examination Gloves | Cheng Chang Development Co., Ltd. | LYY | Class I | |
| K891951 | Three Gun Patient Examination Gloves | Bilwin Corp. | LYY | Class I |