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 |
|---|---|---|---|---|---|
| K970901 | Ge Logiq 500 Diagnostic Ultrasound System | GE Healthcare | IYO | Class II | |
| K970419 | Daxor Max100 Syringe (Max100) | Daxor Corporation | FMF | Class II | |
| K974300 | Telemed Systems Retrieval Basket | TeleMed Systems | OCZ | Class II | |
| K974290 | Microprotein Standard Kit | Verichem Laboratories, Inc. | JIX | Class II | |
| K974171 | Copaxone (Glatiramer Acetate for Injection) Ez-Ject from Shared Solutions | Teva Medical, Ltd. | KZH | Class II | |
| K974154 | Choice Accu-Test Pregnancy Test Kit | SA Scientific, Ltd | LCX | Class II | |
| K974127 | Hydra Meter | Automata Instrumentation, Inc. | FIP | Class II | |
| K974052 | Quickvue Semi-Q Hcg-Combo | Ortho-Clinical Diagnostics, Inc. | JHI | Class II | |
| K974042 | Amsure Cleansing Enema Set | Amsino Intl., Inc. | FCE | Class I | |
| K974021 | Signal Pregnancy Test Kit | SA Scientific, Ltd | LCX | Class II | |
| K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | JDQ | Class II | |
| K974016 | Cerclage Cable with Hex Button | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | JDQ | Class II | |
| K973944 | Orthofix Femoral Nailing Sytem | Orthofix SRL | HSB | Class II | |
| K973893 | Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae | Applied Medical Technologies | KNT | Class II | |
| K973876 | Prophyflex 2, Model 2012 | Kavo America | EFB | Class I | |
| K973853 | Kolplast Vaginal Speculum | Kolplast Comercial E Industrial Ltda | HIB | Class II | |
| K973825 | Midstream Home Regnancy Test | Germaine Laboratories, Inc. | DHA | Class II | |
| K973727 | Electrode, Electrocardiograph | Don Tay Industries | DRX | Class II | |
| K973708 | Tomcat Guide Wire, Extender Wire, Guide Wire Extension Tool | Merit Medical Systems, Inc. | DQX | Class II | |
| K973685 | Revelation Porous Hip Stem | Encore Orthopedics, Inc. | LPH | Class II | |
| K973681 | Natural-Hip Cocr Offset Stem | Sulzer Orthopedics, Inc. | LZO | Class II | |
| K973675 | Natural-Hip Porous Stem with Offset | Sulzer Orthopedics, Inc. | LPH | Class II | |
| K973618 | Somnoplasty System | Somnus Medical Technologies, Inc. | GEI | Class II | |
| K973610 | Skyval | Pyramid Air Systems | FYD | Class II | |
| K973603 | Schwartz Electro-Optics, Inc. Crystalase 1064/532 Laser System | Schwartz Electro-Optics, Inc. | GEX | Class II | |
| K973595 | The Posterior Stabilised Nuffield Total Knee System | Corin USA | JWH | Class II | |
| K973554 | Valley Forge Bipolar Ball Tip Electrode | Valley Forge Scientific Corp. | JOS | Class II | |
| K973291 | Dynamic Hollow Fiber Dialyzer Dc-Series | Dynamic Technology Corp. | FJI | Class II | |
| K972946 | Aurelux 77 | Aurex Precious Metal Industries (Pty)Ltd | EJT | Class II | |
| K972915 | Erbium 2000 Laser Family | Phantom Technologies, Inc. | GEX | Class II | |
| K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | GCJ | Class II | |
| K972314 | Paratrend 7 Neotrend Multiparameter/sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System | Diametrics Medical, Inc. | CCC | Class II | |
| K971086 | Radial and Femoral Artery Catheter | B.Braun Medical, Inc. | DQX | Class II | |
| K970708 | Clirans T-Series Hollow Fiber Dialyzers | Terumo Medical Corp. | FJI | Class II | |
| K964271 | Ign 500 Tm Water Cleaning Unit with Calbenium Liquid | Airel-West | EIA | Class I | |
| K963013 | Preference 60 and Preference 60 Toric | CooperVision, Inc. | LPL | Class II | |
| K962985 | Ksea C.c.l. Vaginal Extractor and Accessories | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K974638 | Steritite Sealed Containers Model Sco4q | Case Medical, Inc. | FRG | Class II | |
| K974454 | Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 | Tucson Medical Corp. | OCT | Class II | |
| K974396 | Irma Blood Analysis System with Optional Lifescan Surestep Pro Blood Glucose Module | Diametrics Medical, Inc. | CHL | Class II | |
| K974223 | Nitrile, Powder Free, Poly Coated Patient Examination Gloves | Derlin Company, Ltd. | LZA | Class I | |
| K974218 | Dermaclean Sterile (Protein Labeling Claim) Exam Gloves | Ansell Perry | LYY | Class I | |
| K974185 | Polymer Nitrile Examination Gloves | Sri Johani Sdn. Bhd. | LZA | Class I | |
| K974184 | High Risk Polymer Latex Examination Gloves (Blue Colour) | Sri Johani Sdn. Bhd. | LYY | Class I | |
| K974183 | Polymer Nitrile Examination Gloves (Blue Colour) | Sri Johani Sdn. Bhd. | LZA | Class I | |
| K974164 | Swiss Lithoclast Master Handpiece and 3.2 Mm Probe | Medical Device Consultants, Inc. | FFK | Class II | |
| K974151 | Vinyl Patient Examination Gloves (Powdered) | Shanghai Super Gloves Co., Ltd. | LYZ | Class I | |
| K974114 | Dash, Vital Gard | Dash Medical Gloves Sdn Bhd | LZA | Class I | |
| K973913 | Medi-Plus, Health-Plus, Sanitex, Reliance | Pwa Industries Sdn. Bhd. | LYY | Class I | |
| K973710 | Digital Add on Multi System | Swissray International, Inc. | KPR | Class II |