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 |
|---|---|---|---|---|---|
| K072238 | Bioset Xch | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | Class II | |
| K072174 | Insucozi Insulin Vial Cover | 41 Industries, LLC | IQG | Class I | |
| K071734 | Waterlase Md Derm | Biolase MG LLC | GEX | Class II | |
| K080024 | Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01 | K2M, Inc | MQP | Class II | |
| K073672 | Skater Biliary Catheter | Angiotech | FGE | Class II | |
| K073654 | Blackstone Ascent Poct System Parallel Rod Connector | Blackstone Medical, Inc. | KWP | Class II | |
| K073529 | Depuy Sigma Ps Femoral Components | Depuy Orthopaedics Inc. | JWH | Class II | |
| K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039 | Possis Medical, Inc. | QEZ | Class II | |
| K073351 | Crystal | Spinal Elements, Inc | ODP | Class II | |
| K073144 | Lanx Intervertebral Body Fusion Device | Lanx, Inc. | MAX | Class II | |
| K073080 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945 | Bio-Rad Laboratories Inc. | JJY | Class I | |
| K073039 | Spermcheck Vasectomy | Princeton BioMeditech Corp. | POV | Class II | |
| K072969 | Dss | Paradigm Spine GmbH | NQP | Class II | |
| K072833 | P-Nain System | Jeisys Medical Inc. | GEX | Class II | |
| K072806 | Mako Surgical Tactile Guidance System (Tgs) | Mako Surgical Corp. | HAW | Class II | |
| K072779 | Ceralas D 980Nm Diode Laser, Models D15 and D25 | Biolitec, Inc. | GEX | Class II | |
| K072777 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Alcon Laboratories | LPL | Class II | |
| K072653 | 3Viseon/surgery | 3Mensio Medical Imaging BV | LLZ | Class II | |
| K072596 | Life+cel or Lifecel Battery Pack, Model 5L500 | Amco International Manufacturing & Design, Inc. | MKJ | Class III | |
| K072166 | Cystatin C Kit for Use on the Spaplus Analyzer | The Binding Site | NDY | Class II | |
| K071240 | Implasa-Hoechst Gmbh Implants | Implasa-Hoechst GmbH | DZE | Class II | |
| K080064 | Flaatz 750 | DRTECH Corporation | MQB | Class II | |
| K080049 | Vascuview Ultrasound System | Escalon Medical Corp | IYO | Class II | |
| K080004 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | NZT | Class II | |
| K073503 | Versa Lite | Diomedics, Inc. | FTC | Class II | |
| K073496 | Optilite Holmium Laser Fibers | Cook Incorporated | GEX | Class II | |
| K073464 | Angiodynamics, Inc., Nevertouch II 400Um Fiber and Venacure Procedure Kit | Boston Scientific Corporation | GEX | Class II | |
| K073406 | Vitek 2 Gram Negative Trimethoprim/sulfamethoxazole | bioMerieux, Inc. | LON | Class II | |
| K073173 | Self-Adhesive Resin Cement | Dentsply Interntional | EMA | Class II | |
| K073018 | Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight | Brainlab, Inc. | IYE | Class II | |
| K073014 | Infiniti 2C9 & Vkorc1 Multiplex Assay for Warfarin | Autogenomics, Incorporated | ODW | Class II | |
| K072906 | Silk'n | Home Skinovations, Ltd. | GEX | Class II | |
| K071883 | Ipulse, Quadra Q4 Platinum Series, Model(s) 1200+Series 2, 1300 Series 2, Q4 Series 2 | Cyden Limited | GEX | Class II | |
| K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model Be-Hmod 2000, Beq-Hmod 2030 | MAQUET CARDIOPULMONARY GmbH | DTZ | Class II | |
| K063223 | Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms | CooperSurgical, Inc. | HDW | Class II | |
| K080038 | Vantage Titan, Model Mrt-1504/S3 | Toshiba America Medical Systems, In.C | LNH | Class II | |
| K073628 | Synocta Abutments | Straumann USA, LLC | NHA | Class II | |
| K073424 | Sensititre 18-24 Hour Susceptibility Plates | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K073093 | Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models Dec19sh24, Dec23sh28, Dec23sh32, Dec31sh36, | Spire Biomedical, Inc. | MSD | Class II | |
| K072875 | Nio 5Mp Display, Model E5620 | Barcoview, Medical Imaging Systems | LLZ | Class II | |
| K072862 | Boston-Band Cranial Remodling Orthosis | Boston Brace Intl., Inc. | OAN | Class II | |
| K072770 | Temporary Pacing Lead, Series Tbb, Model Helios (Tm) | Oscor Inc. | LDF | Class II | |
| K072762 | Depalt Vaginal Specuim and Depalt Lighting System | Depalt, Inc. | HIB | Class II | |
| K072736 | Rhythmlink International Monopolar Stimulating Instrument | Rhythmlink International, LLC | ETN | Class II | |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and Controls | General Atomics | LBR | Class I | |
| K072420 | Magellan-2200, Model-3 Anesthesia Machine | Oceanic Medical Products, Inc. | BSZ | Class II | |
| K062970 | I-Pad | Cu Medical Systems, Inc. | MKJ | Class III | |
| K073587 | Dermapal with Digital Timer | The Daavlin Distributing Co. | FTC | Class II | |
| K073310 | Oasis Ctl Coil, Od Flexible Body Coil (L and Xl), and Rapid Foot Coil | Hitachi Medical Corp. | MOS | Class II | |
| K073292 | Mm/mma/color Series Digital Flat Panel Display System | Heeyoung Co., Ltd. | LLZ | Class II |