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 |
|---|---|---|---|---|---|
| K052973 | Ipump Pain Management System, Model 2L3107, 2L3107k | Baxter Healthcare Corporation | FRN | Class II | |
| K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | KHJ | Class II | |
| K070080 | Intelepacs | Intelerad Medical Systems Incorporated | LLZ | Class II | |
| K063821 | Nova Statstrip Glucose Hospital Meter System | Nova Biomedical Corporation | CGA | Class II | |
| K063794 | Modification to Easyspine System | Ldr Spine USA | MNI | Class II | |
| K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | NRY | Class II | |
| K063322 | Dimension Vista Trf Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control L,control M, Control H | Siemens Healthcare Diagnostics Inc. | DDG | Class II | |
| K063294 | Topacs | Radiological Specialists, Inc. | LLZ | Class II | |
| K063251 | Zimmer M/l Taper Hip Prosthesis with Modular Neck Technology | Zimmer GmbH | KWA | Class III | |
| K063235 | Cytori Lipoplasty System with Celase Reagent | Cytori Therapeutics, Inc. | QPB | Class II | |
| K062765 | Modification to Nuvasive Neurovision Jjb System | NuVasive Inc | GWF | Class II | |
| K060708 | Somnoscreen | Somnomedics GmbH & Co. KG | MNR | Class II | |
| K070035 | Powdered Vinyl Patient Examination Glove | Super Safe Plastic Products Co., Ltd. | LYZ | Class I | |
| K063717 | Cf-1 | Canon, Inc. | HKI | Class II | |
| K063524 | Powder Free Nitrile Examination Gloves (White and Blue Color) | HL Rubber Industries Sdn Bhd | LZA | Class I | |
| K063508 | Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K063483 | Den Tek Nightguard | Den Tek Oral Care, Inc. | MQC | Unclassified | |
| K063475 | Imc-Heartway, Llc Electric Wheelchair, Model Tiara (P4as) | Imc-Heart Way LLC | ITI | Class II | |
| K063410 | Inion Cps/otps Freedomplate | Inion Oy | HRS | Class II | |
| K063196 | Landlex, Model S403x | Besteam Technology, Inc. | INI | Class II | |
| K061602 | Duet System | Bioview | JOY | Class II | |
| K060818 | Architect Shbg Reagent Kit, Architect Shbg Calibrator Kit, and Architect Shbg Control Kit with Models, 8K26-25, 8K26-01 | Biokit, S.A. | CDZ | Class I | |
| K063829 | Thermogard Thermal Regulation System | Alsius Corp. | NCX | Class II | |
| K063604 | Twinky Star Nf | Voco GmbH | EBF | Class II | |
| K063548 | Cor Analyzer 1, Version 1.4 | Rcadia Medical Imaging, Ltd. | LLZ | Class II | |
| K063487 | Merete Blp Small Fragment Locking Bone Plate | Merete GmbH | KTT | Class II | |
| K063476 | Breas Isleep 20I | Breas Medical AB | BZD | Class II | |
| K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199 | Hologic, Inc. | MKZ | Class I | |
| K063439 | Medical Image Management Devices for Vision Tools | Mtd, Inc. | LLZ | Class II | |
| K063434 | Tosca 500 Tcpco2, Spo2 and Pulse Rate Monitoring System | Radiometer Basel AG | DQA | Class II | |
| K063423 | Triathlon Cs (Condylar Stabilizing) Lipped Insert | Howmedica Osteonics Corp | JWH | Class II | |
| K063351 | Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control Low and High | Siemens Healthcare Diagnostics Inc. | NDY | Class II | |
| K063018 | Glass Loss of Resistance Syringe | Busse Hospital Disposables | CAZ | Class II | |
| K062892 | Eukare | Eumed Biotechnology Co., Ltd. | CGA | Class II | |
| K061650 | Select TENS, Model 4600S | Empi | GZJ | Class II | |
| K061414 | Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile Oxygen Storage Tank (Most), Mod | Pacific Consolidated Industries LLC | CAW | Class II | |
| K070006 | Powder-Free Vinyl Patient Examination Gloves | Zibo Hengde Plastic & Rubber Products Co., Ltd. | LYZ | Class I | |
| K063785 | Spiderfx Embolic Protection Device | Medtronic, Inc. | NFA | Class II | |
| K063782 | Accin Uni-Knee System | Accin Corporation | HSX | Class II | |
| K063780 | Ace Bond Se | Bisco Inc | KLE | Class II | |
| K063597 | Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae | bioMerieux, Inc. | LON | Class II | |
| K063561 | Moorldls Laser Doppler Line Scanner | Moor Instruments Ltd. | DPT | Class II | |
| K063372 | Radifocus Glidewire Advantage | Terumo Medical Corp. | DQX | Class II | |
| K063208 | Magnesium Assay (Xb), Models 125-12, 125-50 and 125-S7 | Sekisui Diagnostics P.E.I. Inc. | JGJ | Class I | |
| K063124 | Integra Mozaik Bone Regeneration Matrix - Strips | Integra LifeSciences Corporation | MQV | Class II | |
| K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) | Biomet Manufacturing Corp | KWA | Class III | |
| K062868 | The Crosser Catheter, Model Cr1100 and System Electronics, Model Fg1002-02 | Flowcardia, Inc. | DQY | Class II | |
| K062849 | Smith & Nephew Duonics Power II Shaver System | Smith & Nephew, Inc. | HRX | Class II | |
| K062503 | Catachem, Inc., Bile Acids Reagents And/or Bile Acids Test Kit | Catachem, Inc. | KWW | Class II | |
| K062046 | Modified Merci Retriever, Model 90050 | Concentric Medical, Inc. | NRY | Class II |