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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K242813 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise N.V. | QHE | Class II | |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | MEDLINE INDUSTRIES, LP - Northfield | PAH | Class II | |
| K242435 | Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd | PEM | Class II | |
| K242372 | Mg OSTEOREVIVE™, Mg OSTEOCRETE™ | Bone Solutions, Inc. | MQV | Class II | |
| K242132 | Freddo | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | GEX | Class II | |
| K241959 | 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) | 3M Company | FRC | Class II | |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | SleepNet Corporation | BZD | Class II | |
| K241490 | Contour+ (MVision AI Segmentation) | MVISION AI Oy | QKB | Class II | |
| K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | Edelweiss Dentistry Products GmbH | EBF | Class II | |
| K240916 | Surgical Face Mask (Tie on/ Ear loops) | Xiantao Daoqi Plastic Co., Ltd. | FXX | Class II | |
| K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies Ltd. | JAK | Class II | |
| K240725 | PreXolid CAD/CAM abutments | Eclectic Inc. | NHA | Class II | |
| K240226 | Pixie Skin Tag | Oystershell NV | ORE | ||
| K233378 | ABCcolla® Collagen ADM Scaffold | Acro Biomedical Co., Ltd. | KGN | Unclassified | |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator | Well-Life Healthcare Limited | NUH | Class II | |
| K232994 | Vittra APS Unique Flow | Dentscare Ltda | EBF | Class II | |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | Safepath Medical, Inc. | GAP | Class II | |
| K242899 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | NKB | Class II | |
| K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corp. | BTY | Class II | |
| K242197 | IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) | Shenzhen Huaruibo Electric Appliances Co., Ltd | OHT | Class II | |
| K241337 | Electrically powered wheelchair (HP202) | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | |
| K241267 | Hidroxa SE30 | Hidroxa Medical AB | EGJ | Class II | |
| K241242 | Signa Magnus | GE Healthcare | LNH | Class II | |
| K240711 | Zipline Access Catheter | Perfuze | QJP | Class II | |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel | OMB | Class II | |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager & Meisinger GmbH | DZL | Class II | |
| K240218 | Electric Breast Pump (F5055) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd | HGX | Class II | |
| K240160 | EGPS Navigated Instruments | Astura Medical | OLO | Class II | |
| K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences Inc. | FRO | Unclassified | |
| K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FRG | Class II | |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | KRD | Class II | |
| K242784 | Vy Spine™ VyLam™ Laminoplasty System | VY Spine, LLC | NQW | Class II | |
| K242556 | Jlk-Ctp | JLK, Inc. | LLZ | Class II | |
| K241632 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | |
| K241613 | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) | Shenzhen Hbcare Technology Co.,Ltd | DXN | Class II | |
| K241481 | xvision Spine System | Augmedics Ltd. | SBF | Class II | |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Corp. | FYA | Class II | |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | Cerenovus, Inc. | QJP | Class II | |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | |
| K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 | Ambu A/S | FAJ | Class II | |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences LLC | MUD | Class II | |
| K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division | CJE | Class II | |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | LI Medical Corporation Ltd. | LKF | Class II | |
| K240114 | UltraEzAir® (UEA1A) | Dualams, Inc., dba Airkor | CCT | Class II | |
| DEN230087 | AMStent® Tracheobronchial Covered Stent System | Peytant Solutions | SDB | Class II | |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | JOJ | Class II | |
| K242781 | cvi42 Software Application | Circle Cardiovascular Imaging Inc | QIH | Class II | |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | HIF | Class II | |
| K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | EBF | Class II | |
| K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | QEW | Class II |