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 |
|---|---|---|---|---|---|
| K924947 | Elisa-Doxa Sm | Advanced Biological Products, Inc. | LLL | Class II | |
| K924946 | Elisa-Doxa Ssb | Advanced Biological Products, Inc. | LLL | Class II | |
| K924945 | Elisa-Dpxa Ssa Kit | Advanced Biological Products, Inc. | LLL | Class II | |
| K924473 | Disposable Therapy Electrode | Zimmer Elektromedizin GmbH | GXY | Class II | |
| K923621 | External Demand Pacemaker | Oscor Medical Corp. | DTE | Class II | |
| K923242 | Crosslink Axial and Offset Plates | Sofamor Danek Mfg., Inc. | KWQ | Class II | |
| K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | KWQ | Class II | |
| K920533 | Dentin Bonding Agent | Confi-Dental Products Co. | EBF | Class II | |
| K905262 | Buechel-Pappas Extended Collar Femoral Stem Prosth | Endotec, Inc. | JDI | Class II | |
| K931735 | Blue Line(r) Pdt(tm) Portex Directional Tube | Smiths Industries Medical Systems, Inc. | BTR | Class II | |
| K931053 | Lifepak 10 Defibrillator/monitor W/opt Pacemaker | Physio Control, Inc. | LDD | Class II | |
| K930962 | Captus 2000 Wel Counter | Capintec Instruments, Inc. | IZD | Class I | |
| K926294 | Bbl Crystal Mrsa Id System | Becton Dickinson Microbiology Systems | JWY | Class II | |
| K926257 | Ortholoc Advantim Thick Tibial Base Component | Dow Corning Wright | JWH | Class II | |
| K925892 | Solstice XRAY Ring Marker Pad | Solstice Corporation | JAC | Class I | |
| K925811 | Tsrh Central Post Hooks | Sofamor Danek Mfg., Inc. | KWP | Class II | |
| K925661 | Stockert Caps1 Cardioplegic Control Module | Sorin Biomedica, Fiat, USA, Inc. | KRL | Class II | |
| K925494 | Biomerieux Hemolab Fibrinomat | Biomerieux Vitek, Inc. | GIS | Class II | |
| K924381 | Pwb Lumbar Laminar Hooks with Set Screws | Cross Medical Products, Inc. | KWP | Class II | |
| K923970 | Integrity 2 | Medrotech Corp. | GZJ | Class II | |
| K923353 | Ventilation Tubes W/ Hydrogel Coating | Microbio-Medics, Inc. | ETD | Class II | |
| K922902 | Salman Sinus Button | Boston Medical Products, Inc. | KAM | Class I | |
| K922672 | Augment Posterior Spinal Fixation System | Sofamor Danek Mfg., Inc. | KWP | Class II | |
| K922504 | Isola(r) Tandem Connector | Acromed Corp. | KWP | Class II | |
| K922034 | Lv-20 Volumeter, 20 Mhz Doppler Blood Flow Meter | Titronics Medical Instruments, Inc. | DPW | Class II | |
| K921256 | Luque V Spinal System | Sofamor Danek Mfg., Inc. | KWP | Class II | |
| K931272 | Mist Scissors for Laparoscopic/endoscopic Procedur | Minimally Invasive Surgical Technologies, Inc. | GCJ | Class II | |
| K930931 | Nasal/paranasal Endoscope | Storz Instrument Co. | EOB | Class II | |
| K930763 | Figleaf Shield | Byers Industries, Inc. | IWT | Class I | |
| K930528 | A&e Medical Electrosurgical Connecting Cords | Alto Development Corp | GEI | Class II | |
| K930321 | Becton Dickinson Dispos. Syringes Plunger Tip Mod. | BD Becton Dickinson Vacutainer Systems Preanalytic | FMF | Class II | |
| K930105 | Blom-Singer Low Pressure Voice Prosthesis,p.i.d.s. | Freudenberg Medical, LLC | EWL | Class II | |
| K930053 | Video Camera W/ Electronic Shutter Model Vce-10 | Medical Devices Inc. | FWF | Class I | |
| K926554 | 525 Sfq X-Ray Control W/high Voltage Generator | Tingle X-Ray Products, Inc. | KPR | Class II | |
| K926414 | Valleylab Macrobipolar Forceps Handpiece, E3200 | Medtronic, Inc. | GEI | Class II | |
| K926341 | Unitrocar(tm) Reusable Surg Trocar/resuse Kit | Unisurge, Inc. | GCJ | Class II | |
| K926078 | Dmi Tocar and Cannula System | Diversified Medical Instruments, Inc. | GCJ | Class II | |
| K925830 | Microsurge Suction/irrigation System | Microsurge, Inc. | GEI | Class II | |
| K925790 | Exac-Temp & Clini-Temp Foley Catheter's | DeRoyal Industries, Inc. | EYC | Class II | |
| K925699 | Harmonic Scalpel Laparosonic Clamp Coagulator Acc. | Ultracision, Inc. | GCJ | Class II | |
| K924943 | Eclipse 3200(Tm) Ho:yag Laser for Percu Disketomy | Cardiogenes | GEX | Class II | |
| K924931 | Needle, Pneumoperitoneum, Spring Loaded | Lpc, Inc. | GCJ | Class II | |
| K924921 | Instrumentarium Mega4 Ht | Instrumentarium Imaging, Inc. | LNH | Class II | |
| K924909 | The Bodyguards Ultra Pow-Free Hypo Latex Exam Glov | T.K. Glove Products Co., Ltd. | LYY | Class I | |
| K924713 | Universal Surgical Instrument Holder | T. Korossurgical Instruments Corp. | FWW | Class I | |
| K924649 | Soft-Mist(tm) | Vortran Medical Technology 1, Inc | CAF | Class II | |
| K924240 | Prowess 2000 | Small Systems Group, Inc. | IYE | Class II | |
| K923908 | # 9455 and #9457 Poole Tip Suction Probe | O.R. Concepts, Inc. | GCY | Class I | |
| K923599 | Optilite Fiberoptic Delivery Systems | Xintec Corporation | GEX | Class II | |
| K922840 | Antegrade/retrograde Cardioplegia Valve Systems | Gish Biomedical, Inc. | DTL | Class II |