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 |
|---|---|---|---|---|---|
| K912044 | Model 700 Laparoscopic Electronic Insufflator | Multigon Industries, Inc. | HIF | Class II | |
| K911868 | Interlink(tm) Blunt Cannula, Modification | Baxter Healthcare Corporation | FPA | Class II | |
| K911780 | Infant Nasal Cannulae Assembly, Modified | Ackrad Laboratories | BZD | Class II | |
| K911760 | Monarch Sterilization Container Syst, Modification | Monarch Products, Inc. | FRG | Class II | |
| K911753 | Intervascular Adminstration Set | Mcgaw, Inc. | FPA | Class II | |
| K911634 | Microzyme(tm) Free T4 Enzyme Immunoassay Test | IMMUNOTECH s.r.o. | CEC | Class II | |
| K911506 | Model 2100 Portable Field Unit | Dntl Corp. | EIA | Class I | |
| K911496 | Fasttech System 1 | 3M Diagnostic Systems, Inc. | LSR | Class II | |
| K911449 | Vital-Port Vascular Access System | Med Institute, Inc. | LJT | Class II | |
| K911429 | Vitek Gram Negative Identification Card, Modified | Vitek Systems, Inc. | LQM | Class I | |
| K911425 | Accessories & Connectors, 22Mm-15Mm-8.5Mm | Intersurgical Ltd. | BZA | Class I | |
| K911421 | Catheter Mounts | Intersurgical Ltd. | BZA | Class I | |
| K911353 | Emc Model No. Statome 900 | Emc Industries | HAM | Class II | |
| K911341 | Harmonic Scalpel Endoscopic Blade Coupler Extensio | Ultracision, Inc. | GEI | Class II | |
| K911324 | Irrigation/aspiration Tubing Set | Biomedical Dynamics, Inc. | KDH | Class II | |
| K911047 | Oba(tm) Serum Hcg Assay | Adeza Biomedical | JHI | Class II | |
| K911045 | Oba(tm) Reader | Adeza Biomedical | JJQ | Class I | |
| K910934 | Flo-Gard 6300 Dual Channel Volumetric Infusion Pum | Baxter Healthcare Corporation | FRN | Class II | |
| K910916 | Cathlab Silicone Occlusion Balloon Catheter | Cathlab Corp. | DQT | Class II | |
| K910910 | Moss- Anchor Set | Moss Medical Products | KNT | Class II | |
| K910833 | Color Vue Tm- Mycoplasma Pneumoniae | Seradyn, Inc. | GSA | Class I | |
| K910602 | Hgm Argon Ion & Solid Light Laser for Dentistry | Hgm Medical Laser Systems, Inc. | GEX | Class II | |
| K910487 | Visuwell Syphilis Antigen | Adi Diagnostics, Inc. | LIP | Class II | |
| K910462 | Pocket Dop 3 | Imex Medical Systems, Inc. | HEP | Class II | |
| K910177 | Seal-Rite Silicone Ear Plug | Flents Products Co., Inc. | EWD | Unclassified | |
| K905613 | Mts Knee System | T & R Mfg., Inc. | JWH | Class II | |
| K905024 | Tmp Mandibular Compression System | Techmedica, Inc. | HRS | Class II | |
| K904890 | Bard Alfentanil Infuser | C.R. Bard Inc | FRN | Class II | |
| K904600 | L582 Transducer | Acuson Corp. | MAA | Class II | |
| K904583 | Sono-Vu Us(tm) | E-Z-EM, Inc | HIO | Class I | |
| K904416 | Croatest (R) Rheumatoid Diagnostic | Biotrax, Inc. | GTQ | Class I | |
| K903418 | Lateralase Tm | Trimedyne, Inc. | GEX | Class II | |
| K901552 | (Cp) Titanium and Ti6ai-4V Alloy for Fixed Prosthe | Nobelpharma USA, Inc. | EJH | Class II | |
| K895363 | Biovision Emerald Laser Photocoagulator | F.I.T. of France | GEX | Class II | |
| K911990 | ECG Female-to-Pin Snap Electrode W/leads and Ext. | Somnitec, Inc. | DRX | Class II | |
| K911638 | Syringe Tip Cap | Concord/Portex | JKA | Class II | |
| K911495 | Magnetic Resonance Device Accessory (Mrt-50A) | Toshiba America Mri, Inc. | LNH | Class II | |
| K911394 | Isola(tm) Spine System--Eye Rod | Acromed Corp. | KWP | Class II | |
| K911348 | Rigid Endoscope | Bruel & Kjaer | LNH | Class II | |
| K911100 | Mehigan-Pilling Phlebetome Tm | Pilling Co. | MGZ | Class II | |
| K910592 | Abuscreen Fp for Cannabinoids (15-50) | Roche Diagnostic Systems, Inc. | LDJ | Class II | |
| K910419 | Bioclone's Elegance Ige Elisa Kit | Bioclone Australia Pty, Ltd. | DGC | Class II | |
| K910235 | Pca Mtk II Total Knee System | Howmedica Corp. | JWH | Class II | |
| K910175 | Fixation Devices and Bone Plate | Micro Surgical Instruments Corp. | HRS | Class II | |
| K905526 | Agarrelief 10 Transcutaneous Elec Nerve Stimulator | Agar Ginosar Electronics | GZJ | Class II | |
| K905518 | Berlex Bolus/infusion(tm) Intravenous Admin Set | Venusa Ltd. | IZI | Class II | |
| K905083 | 4.5F Imagecath Angioscope | Baxter Healthcare Corporation | LYK | Class II | |
| K905074 | Microdelta, Tc-99M-Mag3 Renal Processing Program | Siemens Gammasonics, Inc. | IYX | Class I | |
| K904676 | Ndi Model Irs-Td | National Diagnostic Imaging, Inc. | KPR | Class II | |
| K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | LLZ | Class II |