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 |
|---|---|---|---|---|---|
| K891727 | Latex Exam Gloves (Mfg. Rindumas Sdn Bhd) | Baldur Systems Corp. | LYY | Class I | |
| K891726 | Vinyl Exam Gloves (Mfg. Sun Flower Glove Co.) | Baldur Systems Corp. | LYZ | Class I | |
| K891547 | Patient Examination Gloves (Latex) | Huaguang Waterproof Material Co., Ltd. | LYY | Class I | |
| K891435 | Patient Examination Gloves (Latex) | Safeskin Corp. | LYY | Class I | |
| K891423 | Patient Examination Gloves (Latex) | J'Joy Intl., Inc. | LYY | Class I | |
| K891422 | Patient Examination Gloves (Latex) | United Fortune International, Inc. | LYY | Class I | |
| K891417 | Patient Examination Gloves (Latex) | Kossan Latex Industries (M) Sdn Bhd | LYY | Class I | |
| K891389 | Patient Examination Gloves (Latex) | Rubberex (M) Sdn Berhad | LYY | Class I | |
| K891195 | Patient Examination Gloves | Nbs Maronix Rubber Co., Ltd. | LYY | Class I | |
| K890776 | Langs Exam Glove | Langs Intl., Inc. | LYY | Class I | |
| K890440 | Latex Decontamination/procedure Gloves (Non-Ster) | Tomarc (M) Sdn Bhd | LYY | Class I | |
| K884557 | Advanced Surgical Products Scissors Handpiece | Advanced Surgical Products, Inc. | HQE | Class II | |
| K892745 | Patient Examination Gloves (Latex) | Wei Shung Industrial Co., Ltd. | LYY | Class I | |
| K892744 | Patient Examination Gloves (Latex) | Chien Lung Rubber Co., Ltd. | LYY | Class I | |
| K892739 | Patient Examination Gloves (Latex) | Yu Cheng Furniture Industrial Co., Ltd. | LYY | Class I | |
| K892738 | Patient Examination Gloves (Latex) | Sung Tai Industrial Co., Ltd. | LYY | Class I | |
| K892737 | Patient Examination Gloves (Latex) | Kds Latex Industrial Co., Ltd. | LYY | Class I | |
| K892693 | Vaginal Specula: Cusco, Guttman, Infant | Zinnanti Surgical Instruments, Inc. | KOH | Class I | |
| K892681 | Patient Examination Gloves (Latex) | United States Import Sales | LYY | Class I | |
| K892546 | Taylor Spinal Retractor | Zinnanti Surgical Instruments, Inc. | HAO | Class I | |
| K892535 | Neurological Rongeurs - Various Types | Zinnanti Surgical Instruments, Inc. | HAE | Class II | |
| K892527 | Duoderm* Transparent Hydrocolloid Dressing-Modify | Convatec, A Division of E.R. Squibb & Sons | NAD | Class I | |
| K892523 | Gambro Alwall Gfs 11,12,Plus 12 Hollow Fiber Dialy | Gambro, Inc. | FJI | Class II | |
| K892332 | Drugs of Abuse Urine Calibrators | Hycor Biomedical | DKB | Class II | |
| K892291 | Patient Exam Gloves (Mfg. American Rubber Product) | American Health Products, Inc. | LYY | Class I | |
| K892272 | Patient Examination Glove (Latex) | Wagania Sdn. Bhd. | LYY | Class I | |
| K892235 | Ge Shoulder Surface Coil, Cat. #M1085an | General Electric Co. | LNH | Class II | |
| K892128 | Patient Examination Gloves (Latex) | Excel U.S.A. | LYY | Class I | |
| K892063 | Thermomax Microplate Reader, Modification | Molecular Devices Corp. | JJQ | Class I | |
| K891911 | Argedent 52Sf | Argen Precious Metals, Inc. | EJT | Class II | |
| K891775 | Mandibular Lip Bumper and Lip Bumper Tubes | American Orthodontics | EJF | Class I | |
| K891717 | Patient Examination Gloves (Vinyl) | Ulti-Med Intl., Inc. | LYZ | Class I | |
| K891630 | Patient Examination Gloves (Latex) | Inter-Continental Industries Sdn Bhd | LYY | Class I | |
| K891598 | Model 2030; 3 Tmj Surface Coil | Medical Advances, Inc. | LNH | Class II | |
| K891586 | Oral Airway | Dynarex Corp. | CAE | Class I | |
| K891541 | Magnetic Resonance Device Accessory Software 4.0. | Diasonics, Inc. | LNH | Class II | |
| K891483 | First Aid Survival Kit | Elwyn, Inc. | LRR | Not classified | |
| K891465 | Obstetric Cup (Modification) | Go Medical Industries Pty., Ltd. | HDB | Class II | |
| K891428 | Patient Examination Gloves (Latex) (Powdered) | Bio-Aid Industries Sdn Bhd | LYY | Class I | |
| K891398 | Retractor Rods | Zinnanti Surgical Instruments, Inc. | KNA | Class II | |
| K891351 | Newport Lateral Vaginal Retractor | Simpson/Basye, Inc. | KOH | Class I | |
| K891148 | Model 152 Delta Holter ECG Analysis System | Del Mar Avionics | DSI | Class II | |
| K891005 | Intravascular Admini. Set Models 60030 & 60050 | 3M Company | FPK | Class II | |
| K890975 | Patient Examination Glove | Kleartex Sdn Bhd | LYY | Class I | |
| K890970 | Truvel Tz-3X X-Ray Digitizing Scanner | Truvel Corp. | LMA | Class II | |
| K890848 | Cervex-Brush | Unimar, Inc. | HHT | Class II | |
| K890824 | Fresenius 2008 Touch Panel Control Dialysis System | Fresenius USA, Inc. | FKP | Class II | |
| K890329 | Fresenius 2008 Bss Bedside Dialysis System | Fresenius USA, Inc. | FIL | Class II | |
| K890102 | Itc & Ite Hearing Aid, Hear Clear Models 1-4 | Hear Clear, Inc. | ESD | Class I | |
| K890084 | Psoralite Phototherapy Treatment Booth, Mdl 45000 | Psoralite Corp. | FTC | Class II |