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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-Zzzz | Implex Corp. | JDK | Class II | |
| K033345 | An5150 and An7150 Digital Radiology Systems | Analogic Corp. | KPR | Class II | |
| K033320 | Scout Pro | BIOTRONIK AG | DQY | Class II | |
| K033188 | Texan Foreign Body Retrieval Device, Model Tx30060050 | Idev Technologies, Inc. | MMX | Class II | |
| K033187 | Interlab Immunofixation Test(s) | Interlab S.r.l. | CFF | Class II | |
| K032869 | Cook Coda Balloon Catheter | Cook Inc. | DQY | Class II | |
| K032802 | Hk Liposuction Aspirator, Model Ap-III & Ap230-III | HK Surgical Inc | QPB | Class II | |
| K033473 | Modification to Vortex Mp Vascular Access Port | Boston Scientific Corporation | LJT | Class II | |
| K033350 | Bd Vacutainer Safety-Lok Administration Set with Filter | Becton Dickinson & Co | FPA | Class II | |
| K033119 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K032784 | Ilt Safe-Cross Deflecting Catheter, Model C114nd1 | Intra Luminal Therapeutics, Inc. | DQY | Class II | |
| K032753 | Glucose Tolerance Beverage | Perk Scientific, Inc. | MRV | Class II | |
| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020 | Remel, Inc. | MHI | Class II | |
| K031666 | Arthrex Fiberwire Button Repair Kit, Model Ar-8920Ds/ar-8921Ds | Arthrex GmbH | HRS | Class II | |
| K031553 | Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes | Arcadia Medical Corporation | BTO | Class II | |
| K031541 | Paradigmpal, Model Mmt-7330 | Minimed, Inc. | LZG | Class II | |
| K031463 | Marina Medical Silicone Pessary | Marina Medical Instruments Inc. | HHW | Class II | |
| K021478 | Delta Shoulder | Depuy, Inc. | PHX | Class II | |
| K033134 | Modification to Paramount Mini Stent and Delivery System | Medtronic, Inc. | FGE | Class II | |
| K033115 | Orthodek | Teleflex Medical | GAM | Class II | |
| K032987 | Accutest Hcg-Combo Model,hcg-004, Accustrip Hcg-Combo Model, Hcg-005 | Unotech Diagnostics, Inc. | JHI | Class II | |
| K032586 | Caprosyn Absorbable Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K032539 | Cynosure Photogenica Sv Laser | Cynosure, LLC | GEX | Class II | |
| K032160 | Artelon Surgical Suture | Artimplant AB | GAR | Class II | |
| K024286 | Gyrus Open Forceps | Gyrus ACMI, Inc. | GEI | Class II | |
| K024206 | Aura Isurgical Laser System & Accessories | Laserscope | GEX | Class II | |
| K011261 | Stone Extractor Balloon Catheter | Medi-Globe GmbH | FGE | Class II | |
| K033468 | Affinity 20U Arterial Filter with Trillium Biosurface | Medtronic Perfusion Systems | DTM | Class II | |
| K033358 | Chronic Pain Suppressor Cps-2000, Model Cps-2000 | Surgitech, Inc. | LIH | Class II | |
| K033353 | Modification to Liberty 5000 Breast Coil with Disposable Biopsy Plates | GE Healthcare Coils | MOS | Class II | |
| K033333 | Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | Class II | |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | HSB | Class II | |
| K033238 | Mobilette Xp and Mobilett Xphybrid | Siemens Medical Solutions USA, Inc. | IZL | Class II | |
| K033007 | Bayer Advia Digoxin Assay for the Integrated Module System | Bayer Diagnostics Corp. | KXT | Class II | |
| K032967 | Pascal Dynamic Contour Tonometer | Smt Swiss Microtechnology AG | HKY | Class II | |
| K032777 | Modification to: Nipro Safe Touch Safety Fistula Needle | Nipro Medical Corporation | FOZ | Class II | |
| K032670 | Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera Green Color | Kingswell International, Inc. | LYZ | Class I | |
| K032636 | Playtex Unscented Cardboard Applicator Tampon #13203 (Colored) and # 13203 Pv (Non-Colored) | Playtex Products, Inc. | HEB | Class II | |
| K032543 | Sirona Dental Systems C8+dental Operative Unit with Accessories | Sirona Dental Systems GmbH | EIA | Class I | |
| K032521 | Bard Dual Lumen Ureteral Catheter | C.R. Bard Inc | EYB | Class II | |
| K032094 | Passmed Spinal System | Medicrea | KWP | Class II | |
| K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 | Remel, Inc. | MHJ | Class II | |
| K031646 | Bausch & Lomb Multi-Purpose Solution Nrc03 | Bausch & Lomb Incorporated | LPN | Class II | |
| K031515 | Spiropro Spo2 | Viasys Healthcare GmbH | DQA | Class II | |
| K031380 | Olympus Hba1c Reagent, (Catalog Number Osr6192), Olympus Hba1c Calibrator, (Catolog Number Odc3032) | OLYMPUS Corporation of the Americas | LCP | Class II | |
| K031236 | Auto-Band Ligator | Scandimed. A.S. | MND | Class II | |
| K031175 | Click'x Monoaxial Screws and Hooks | Synthes (USA) Products LLC | KWP | Class II | |
| K031024 | Microlife Electronic Peak Flow Monitor, Model Pf-100 | Microlife Corp. | BZH | Class II | |
| K031007 | Kwikeze Male Condom Applicator | Condax, LLC | HIS | Class II | |
| K030792 | Bard Endotracheal Tube, Cuffed | C.R. Bard Inc | BTR | Class II |