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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K161985 | Steerable Guide Catheter | Abbott Vascular | DRA | Class II | |
| K153276 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | NAY | Class II | |
| K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl | First Quality Hygienic, Inc. | HEB | Class II | |
| K161867 | On Call Pro Blood Glucose Monitoring System | Acon Laboratories, Inc. | NBW | Class II | |
| K161706 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics L | IYN | Class II | |
| K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | MED | Class II | |
| K161245 | EP-TRACER System | Cardio Tek, BV | DQK | Class II | |
| K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | GE Healthcare | IYN | Class II | |
| K161113 | QXLink | Vieworks Co., Ltd. | LLZ | Class II | |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | Nonin Medical, Inc | DQA | Class II | |
| K160806 | Verza Guidance System | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K160483 | Burn-out Cylinder and Angled Screw Abutments | Dentium Co., Ltd. | NHA | Class II | |
| K160338 | Triton System | Gauss Surgical, Inc. | PBZ | Class II | |
| K160248 | ArgenIS Titanium Abutments | The Argen Corporation | NHA | Class II | |
| K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K161986 | SIDEKICK and USHER Support Catheters | Bard Peripheral Vascular Inc | DQY | Class II | |
| K161798 | FacetBRIDGE® System | Ldr Spine USA | MRW | Unclassified | |
| K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | Spineway | NKB | Class II | |
| K161286 | IPL Therapy Machine | Beijing Adss Development Co., Ltd. | ONF | Class II | |
| K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega Sdn Bhd | LYY | Class I | |
| K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | MHX | Class II | |
| K160563 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Hartalega Sdn Bhd | LZA | Class I | |
| K160281 | Ossix Plus | Datum Dental, Ltd. | NPL | Class II | |
| K153756 | Microlyte Ag | Imbed Biosciences Inc. | FRO | Unclassified | |
| K153744 | A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) | A1 Glove Sdn Bhd | LYY | Class I | |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | Axis-Shield Diagnostics, Ltd. | NHX | Class II | |
| K153549 | Ossix Volumax | Datum Dental, Ltd. | NPL | Class II | |
| K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | Safe Secure Packaging Co., Ltd. | FRG | Class II | |
| K153329 | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis | Med-Tech Water Systems, Inc. | FIP | Class II | |
| K153274 | Med-Tainer Single Deposit Container | Snyder Industries, Inc. | MMK | Class II | |
| K153243 | Fehling-Punches | Fehling Instruments GmbH & Co. KG | HAE | Class II | |
| K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply | Smith & Nephew Medical Ltd | OMP | Class II | |
| K152471 | Capo Bulk Fill | Schuetz Dental GmbH | EBF | Class II | |
| K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | DXT | Class II | |
| K161289 | DURAFIBER Ag | Smith & Nephew Medical Ltd | FRO | Unclassified | |
| K161234 | CASSI II Rotational Core Biopsy System | Scion Medical Technologies, LLC | KNW | Class II | |
| K161033 | AFX™ Femoral Implant With Inserter | Cayenne Medical Inc. | MBI | Class II | |
| K160774 | IonoStar Plus | Voco GmbH | EMA | Class II | |
| K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | BWF | Class II | |
| K160284 | JointPoint | Jointpoint, Inc. | LLZ | Class II | |
| K160219 | Hilal Embolization MicroCoils | Cook Incorporated | KRD | Class II | |
| K151757 | IMMEDIATELOAD Dental Implant System | Immediateload S.A. | DZE | Class II | |
| K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | Kossan International Sdn Bhd | LZA | Class I | |
| K151542 | A-Oss | Hiossen, Inc. | NPM | Class II | |
| K161896 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | HRS | Class II | |
| K161864 | ARIX Foot System | Jeil Medical Corporation | HRS | Class II | |
| K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem | Mermaid Medical A/S | KNW | Class II | |
| K161220 | ARIES® Flu A/B & RSV Assay | Luminex Corporation | OCC | Class II | |
| K160675 | Powder free vinyl patient examination glove, colored (yellow) | Kaixing Plastic Products Co., Litd. | LYZ | Class I |