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 |
|---|---|---|---|---|---|
| K946144 | Liquispex(tm) Urine Ethanol Control | Clinical Controls, Inc. | JJX | Class I | |
| K946024 | 3M Pediatric Laparotomy Sheet #7938/ #7938Ns | 3M Healthcare | KKX | Class II | |
| K945963 | The Omniguide Guiding Catheter with Balloon | Micro Interventional Systems, Inc. | DQT | Class II | |
| K945951 | Quikpac II, One Step Hcg Combo Kit | Syntron Bioresearch, Inc. | JHI | Class II | |
| K945689 | Game Audiometery Word Identification Audiometry for Use with Prodigit(tm) 2000 Personal Digital Audiometer(tm) | Calmed Technology, Inc. | EWO | Class II | |
| K945584 | Nova 16 Analyzer | Nova Biomedical Corporation | JJC | Class I | |
| K945243 | Catalogue Number 321-07/15/50 | Sekisui Diagnostics P.E.I. Inc. | JFJ | Class II | |
| K945184 | Intravascular Administration Set | Distronic Sterile Products, Inc. | FPK | Class II | |
| K945171 | Disposable & Resuable Irrigation/aspiration Handpiece | Boston Surgical Products, Inc. | KYG | Class I | |
| K944816 | Sureview Mqsa Option Kits (Model No.'s 377095 & 377096) | Philips North America LLC | IZH | Class II | |
| K944733 | Plum Xl Infusion Pump | Abbott Medical | FRN | Class II | |
| K944677 | Scimed Transent Ex Steerable Guide Wire and Accessories | Scimed Peripheral Interventions | DQX | Class II | |
| K944372 | Stc Diagnostic Auto-Lyte Propoxyphene Eia | Solarcare, Inc. | JXN | Class II | |
| K944250 | Urea Nitrogen Reagent | Olympus Corp of America | CDQ | Class II | |
| K943694 | Ebi Anterior Cervical Spine System | Electro-Biology, Inc. | KWQ | Class II | |
| K942349 | Microbore Extension Set | Excelsior Medical LLC | FPA | Class II | |
| K942107 | Magic Ear, Elain | Novaplex, Inc. | ESD | Class I | |
| K941306 | Foundation Knee Augmentation Blocks | Encore Orthopedics, Inc. | JWH | Class II | |
| K940917 | Loracarbef Gram-Nagative Panels | Baxter Diagnostics, Inc. | JWY | Class II | |
| K940817 | Tdx(r)/tdxflx(r) Fetal Lung Maturity II | Abbott Medical | JHF | Class II | |
| K934523 | Gill-Thomas-Cosman (Gtc) Relocatable Head Holder System with Depth Confirmation Helmet(dh-1) | Radionics, Inc. | IYE | Class II | |
| K934381 | Apollo Knee Tibial Baseplate/knee Tibial Insert | Intermedics Orthopedics | JWH | Class II | |
| K932356 | Nova Xm2 | Dynarad Corp. | IZH | Class II | |
| K926106 | Immuchem Phe-Mw Ea | Icn Biomedicals, Inc. | JNB | Class II | |
| K920038 | Neurosearch-4 | Lexicor | HCC | Class II | |
| K915820 | Neurosearch-24 or Nrs-24 | Lexicor Medical Technology, Inc. | OLT | Class II | |
| K950283 | Lifestyle 4-Vue(tm) (Polymacon) Hydrophilic Contact Lens | Permeable Technologies, Inc. | LPL | Class II | |
| K950176 | Premie U-Bag Urine Specimen Collector | Hollister, Inc. | FOC | Class II | |
| K950125 | Karl Storz Bougies and Dilators | Karl Storz Endoscopy-America, Inc. | FAX | Class I | |
| K950086 | Pedia Pals, Incorporated | Pedia Pals, Inc. | EPY | Class I | |
| K950079 | Sunglasses | Gianni Versace | HQY | Class I | |
| K946357 | Collagen Intracanalicular Plug | Oasis Medical, Inc. | LZU | Unclassified | |
| K946119 | Roche-Tdm Onlein(tm) Controls | Roche Diagnostic Systems, Inc. | LAS | Class I | |
| K946101 | Emergency/accident Trolley 550 | Hogan & Hartson | FPO | Class II | |
| K945998 | Chin Implant Style I | King & Spalding | FWP | Class II | |
| K945981 | Lifestyle 55 (Methafilcon a) Soft Hydrophilic Contact Lens | Permeable Technologies, Inc. | LPL | Class II | |
| K945955 | Rose K Lens | Rose K International, Ltd. | HQD | Class II | |
| K945813 | Becton Dickinson Precision Cut(tm) Coaxial Introducer Needle with Depth Stop | BD Becton Dickinson Vacutainer Systems Preanalytic | FCG | Class II | |
| K945789 | Deroyal Disposable Insufflation Tubing Filter | DeRoyal Industries, Inc. | HIF | Class II | |
| K945763 | Low Temperature Cautery Elongated Fine Tip | Apyx Medical Corporation | HQP | Class II | |
| K945762 | Low Temperature Cautery Fine Tip, Adjustable | Apyx Medical Corporation | HQP | Class II | |
| K945680 | Metzler, Alpina, Menrad, Police, L. Biagiotti, Cff, R. Lauren, Polo, Neometal, L'amy, Neostyle Etc. | Solex Marketing, Inc. | HQY | Class I | |
| K945675 | Preppies Skin Barrier Wipe | Kendall Healthcare Products Co. Div.Of Tyco Health | FRO | Unclassified | |
| K945567 | Qc Cap | Medionics International, Inc. | KDJ | Class II | |
| K945499 | Cato First Picc Kit | Catco Medical, Inc. | LJS | Class II | |
| K945472 | Westmed Pediatric and Adult Aerosol Mask | Westmed Intl. | BYG | Class I | |
| K945389 | Ivr Master | Shimadzu Corp. | LLZ | Class II | |
| K945210 | Ksea Disposable Tubing Set for the Uromat Pump | Karl Storz Endoscopy-America, Inc. | LJH | Class II | |
| K945088 | Gabriel Ureteral Illuminator System II | Gabriel Medical, Inc. | FCS | Class II | |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid}) | JEDMED Instrument Company | EOB | Class II |