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 |
|---|---|---|---|---|---|
| K010983 | Plla Pin | Bionx Implants, Inc. | HTY | Class II | |
| K010854 | Chlorinated Powder-Free Latex Examination Gloves, (Blue, Green) | Protection Gloves Sdn. Bhd. | LYY | Class I | |
| K010831 | Aviator Peripheral Dilatation Catheter | Boston Scientific Corporation | DQY | Class II | |
| K003909 | Proact 1 | Proact, Ltd. | IRP | Class II | |
| K003259 | Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model 34470,34475,34479 | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K002727 | Young-Health Super Ear Thermometer | Young Health Ind. Co., Ltd. | FLL | Class II | |
| K002695 | Memodyn Staple | Telos Medical Equipment | JDR | Class II | |
| K011605 | Emit 2000 Quinidine Assay, Model Osr4q229 | Syva Co., Dade Behring, Inc. | LBZ | Class II | |
| K011529 | T2 Humeral Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K011508 | Cd Horizon Spinal System | Medtronic Sofamor Danek | KWP | Class II | |
| K011433 | Ballert Cranial Molding Helmet | Gema, Inc. | MVA | Class II | |
| K011420 | Mm-87 Motor-Drive Manipulator | Narishige Co., Ltd. | MQJ | Class II | |
| K011336 | Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock | Vygon Mfg | FPA | Class II | |
| K011193 | Nac Plus Needleless Access Connector | Porex Medical Products | FPA | Class II | |
| K011007 | Tenodesis Screw, 5.5 Mm, Model Ar-1350-55 | Arthrex GmbH | MBI | Class II | |
| K010972 | Isola Band Clamp | Depuyacromed | MNI | Class II | |
| K010945 | Heartcard, Model 5258 | Instromedix, Inc. | DXH | Class II | |
| K010780 | Trochanteric Nail | Depuy Orthopaedics Inc. | HSB | Class II | |
| K010775 | Biocellect | Imtec Corp. | LYC | Class II | |
| K010770 | Bci Advisor Vital Signs Monitor (9200) | Bci, Inc. | MWI | Class II | |
| K010766 | Synthes (USA) Large Fragment Locking Compression Plate (Lcp) System-T Plate | Synthes (USA) Products LLC | KTT | Class II | |
| K010209 | Electro-Nerve Stimulator TENS, Model He-Digital | BioMedical Life Systems Inc. | GZJ | Class II | |
| K010181 | Cd Horizon Spinal System, 4.5 Rod for Posterior Application | Medtronic Sofamor Danek | KWP | Class II | |
| K003207 | Medcomp Ultra-Flow Catheter | Medical Components, Inc. | MSD | Class II | |
| K003047 | Ambulatory Enteral Nutrition Pump | Ross Product Div. Abbott Laboratories | LZH | Class II | |
| K001897 | Multi-Stim, Model Ms-100 | Metron Medical Australia, Pty, Ltd. | GZJ | Class II | |
| K001281 | Geratherm Babywatch Temperature Monitor | Geratherm AG | FLL | Class II | |
| K011431 | Resin Cem | S & C Polymer GmbH | EMA | Class II | |
| K010951 | Island Wound Dressing with Microban | Island Dressing, LLC | FRO | Unclassified | |
| K010760 | Art Bicarbonate for Hemodialysis, Art Bicarbonate Liquid for Hemodialysis | Advanced Renal Technologies, Inc. | KPO | Class II | |
| K010752 | Aesculap's Modular Endoscopic Instruments for Gynecology | Aesculap Inc | KNF | Class II | |
| K010751 | Bpfone, Model Ua 767It | Medical Monitors, Inc. | DXN | Class II | |
| K010634 | Heartstream Xl Defibibrillator/monitor, Model M4735a, Heartstream Xlt Defibrillator/monitor.model M2500b | Agilent Technologies, Inc. | MKJ | Class III | |
| K010301 | Immunowell Ea (D) Igg Test | Genbio | LSE | Class I | |
| K004017 | H-Scribe | Mortara Instrument, Inc. | MLO | Class II | |
| K003190 | En Bloc Biopsy System | Neothermia Corp. | GEI | Class II | |
| K011624 | Expedio 500D r&f X-Ray System | GE Healthcare | JAA | Class II | |
| K011617 | Lifejet Printer 400 | Ferrania S.p.A. Stabilimento di Ferrania | LMC | Class II | |
| K011611 | Cardiocam Model 9Csy0799 | Danish Diagnostic Development A/S | KPS | Class II | |
| K011610 | Livesure Methamphetamine Screen Tests | Pan Probe Biotech, Inc. | LAF | Class II | |
| K011609 | Livesure Amphetamine Screen Test | Pan Probe Biotech, Inc. | DKZ | Class II | |
| K011601 | Ardo Suction Pump Master, Model 30.00.Xx; Ardo Suction Pump Senator, Model 31.00.Xx | Ardo Medical AG | BTA | Class II | |
| K011578 | M2376a Devicelink System, Model M2376a | Agilent Technologies, Inc. | MWI | Class II | |
| K011545 | Verdict -II Tca, Verdict-II Mtd | MEDTOX Diagnostics, Inc. | LFG | Class II | |
| K011516 | Infant Flow System, Model M672p | Eme (Electro Medical Equipment), Ltd. | BZD | Class II | |
| K011494 | Liquichek Immunology Control Level 1,2,3,1, Ml, Liquichek Immunology Control Level 1, 3 Ml, Liquichek Immunology Control | Bio-Rad | JJY | Class I | |
| K011465 | Synchron Cx Pro Clinical Systems, Model Cx4 Pro, Cx5 Pro, Cx7 Pro, Cx9 Pro | Siemens Healthcare Diagnostics Inc. | LDP | Class II | |
| K011417 | Ultrasound Scanner, Type 2102 | BK Medical ApS | IYO | Class II | |
| K011159 | One-Step Plus | Bisco Inc | EMA | Class II | |
| K011132 | Airlife Hepa Filter | Medtronic, Inc. | CAH | Class II |