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 |
|---|---|---|---|---|---|
| K021034 | Modified Tfx Medical Safety Needle with Introducer | Tfx Medical, Inc. | KNT | Class II | |
| K020974 | Bara-Med Acrylic Monoplace Hyperbaric Chamber | Environmental Tectonics Corp. | CBF | Class II | |
| K020056 | Duet Suture Anchor | Bionx Implants, Inc. | HWC | Class II | |
| K014282 | Bacstop Filter,bacstop Filter/hme | Munktell Filter AB | CAH | Class II | |
| K014281 | Gard Filter, Combigard Filte / Hme | Munktell Filter AB | CAH | Class II | |
| K014114 | Glucopro Syringe, Model Gpsy-Xxxxxxxx | Nipro Diabetes Systems, Inc. | FMF | Class II | |
| K012308 | Kavo Quattrocare | Kavo America | EFB | Class I | |
| K021930 | Medica Easyqc Blood Gas/electrolyte Control | Bionostics, Inc. | JJY | Class I | |
| K021922 | Modification to Para 5X | Streck Laboratories, Inc. | JPK | Class II | |
| K021241 | Sysmex Xt-Series, Model Xt-2000I and Xt-1800I | Sysmex Corporation of America | GKZ | Class II | |
| K021030 | Titanium Cannulated Interference Screw | Future Medical Systems, Inc. | HWC | Class II | |
| K021012 | Laminaria 2Mm/3mm/4mm/5mm/6mm/7mm/8mm/9mm | Quality Medical Solusions, LLC | HDY | Class II | |
| K020987 | Bmn I Type Marrow Aspiration Needle | H.S. Hospital Service S.p.A. | KNW | Class II | |
| K020985 | Modified Tfx Medical Safety Needle with Introducer | Tfx Medical, Inc. | KNT | Class II | |
| K020296 | Adult Silicone Ear Plugs, Models # 68053, 68057 | Apothecary Products, LLC | EWD | Unclassified | |
| K014166 | Uhi-3 High Flow Insufflation Unit | Olympus Optical Co., Ltd. | HIF | Class II | |
| K021924 | Medica Easyqc Hematocrit Control | Bionostics, Inc. | GLK | Class II | |
| K021912 | M2376 Devicelink System | Philips North America LLC | MWI | Class II | |
| K021144 | Subdural Strip Electrode | Nicolet Biomedical, Inc. | GYC | Class II | |
| K020996 | Medefil's Heparin i.v. Flush Syringe in Various Fill Sizes - 1 Ml Fill in 6 Ml Syringe Ll; 2 Ml Fill in 6 Ml Syringe Ll | Medefil, Inc. | NGT | Class II | |
| K020666 | Duploject Easy-Prep System 1Ml, 2Ml, 5Ml | Baxter Healthcare Corporation | FMF | Class II | |
| K020205 | Castle Peracetic Acid Biological Indicator Kit | Getinge/Castle, Inc. | FRC | Class II | |
| K014018 | Cholesterol 1, 2, 3 | Imi | LBS | Class I | |
| K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | MNW | Class II | |
| K013593 | Cardeon Aegis Catheter | Cardeon Corp. | DWF | Class II | |
| K013309 | Glucopro Evo Infusion Pump | Nipro Diabetes Systems, Inc. | LZG | Class II | |
| K012648 | Reprocessed Howmedica External Fixation Devices | Alliance Medical Corp. | KTT | Class II | |
| K012645 | Reprocessed Ebi External Fixation Devices | Alliance Medical Corp. | KTW | Class II | |
| K012634 | Reprocessed External Fixation Device | Alliance Medical Corp. | KTW | Class II | |
| K012623 | Reprocessed External Fixation Device | Alliance Medical Corp. | KTT | Class II | |
| K021787 | Visucam | Carl Zeiss Meditec Inc | NFF | Class I | |
| K021729 | Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology | Sulzer Intratherapeutics, Inc. | FGE | Class II | |
| K021714 | Rt-Plus Pe Insert Clamp | Plus Orthopedics | KRO | Class II | |
| K021706 | Horizons Hot Biopsy Forceps | Horizons Intl. Corp. | KGE | Class II | |
| K021701 | Surgassist Right Angle Linear Cutter 30Mm, 45Mm & 60Mm, Models Ralc30, Ralc45 & Ralc60 | Power Medical Interventions, Inc. | GDW | Class II | |
| K021683 | Cinescan S | Quantel Medical | IYO | Class II | |
| K021043 | Grams Absorbable Surgical Gut Suture Plain & Chromic | Gramsmed, LLC | GAL | Class II | |
| K020980 | Dimension Tpsa Calibrator, Model #Rc459 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K020958 | Candela Cbeam Pulsed Dye Laser System | Candela Corporation | GEX | Class II | |
| K020378 | Qupid Plus E.r. | Stanbio Laboratory | JHI | Class II | |
| K013814 | Absorbent Antimicrobial Wound Dressing | Convatec, A Division of E.R. Squibb & Sons | FRO | Unclassified | |
| K021721 | Equalizer Balloon Catheter | Boston Scientific Corporation | DQY | Class II | |
| K021695 | Ebi Dynafix Diaphyseal Correction System | Ebi, LLC | KTT | Class II | |
| K021627 | Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K021613 | Niveous Liquid Dam | Shofu Dental Corp. | EIE | Class I | |
| K021184 | Microscan Microstrep Plus Panel New Antimicrobial-Clindamycin | Dade Microscan, Inc. | LTT | Class II | |
| K021008 | Advanced Orthopaedic Solutions Trochanteric Nail | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | |
| K020999 | Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 Ml Fill in 6 Ml Syringe Ll; 2 Ml Fill in 6 Ml Syringe Ll | Medefil, Inc. | NGT | Class II | |
| K020967 | Terumo Khuri Myocardial Ph Monitoring System | Terumo Cardiovascular Systems Corporation | CBZ | Class II | |
| K020639 | Tipower Tr Rimpower and Tipower Tra Rimpower | TiSport, LLC | ITI | Class II |