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 |
|---|---|---|---|---|---|
| K240638 | Power Wheelchair (YH-E7007) | Ningbo Youhuan Automation Technology Co., Ltd. | ITI | Class II | |
| K234089 | DNA Appliance | Vivos Therapeutics Inc. | LRK | Class II | |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | O&M Halyard, Inc. | FRG | Class II | |
| K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | HBC | Class II | |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 | Medline ReNewal | NLH | Class II | |
| K242441 | Revian Lyte (10011) | REVIAN, Inc | OAP | Class II | |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | MEH | Class II | |
| K241722 | Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment | Elos MedTech Pinol a/S | NHA | Class II | |
| K240977 | DenQ Sub SLA Implant System | Denq Co., Ltd. | DZE | Class II | |
| K240929 | Sleep Apnea Notification Feature (SANF) | Apple Inc. | QZW | Class II | |
| K240544 | Epitomee | Epitomee Medical Ltd. | QFQ | Class II | |
| K240232 | EK D3.3 and Ultra Wide Implants | Hiossen, Inc. | DZE | Class II | |
| K240188 | Vitruvian Liposaber | Black & Black Surgical, Inc. | QPB | Class II | |
| K240176 | V-VITFREEZE and V-VITWARM | VITROMED GmbH | MQL | Class II | |
| K240087 | RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. | DSA | Class II | |
| K234063 | T2Candida 1.1 Panel | T2biosystems, Inc. | PII | Class II | |
| K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | JWH | Class II | |
| K242136 | Electric wheelchair (C001) | Zhejiang Hfizer Medical Equipment Co.,Ltd | ITI | Class II | |
| K241710 | 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M | 3M Company | FRC | Class II | |
| K241695 | Extremity All Suture System | Field Orthopaedics | MBI | Class II | |
| K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Canon Medical Systems Corporation | IYN | Class II | |
| K241524 | Elucid PlaqueIQ | Elucid Bioimaging | LLZ | Class II | |
| K241493 | Glidewell™ 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | |
| K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K241280 | Constellation (CON-001) | Q Bio | QIH | Class II | |
| K241249 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) | Palodex Group Oy | OAS | Class II | |
| K240942 | CINA-CSpine | Avicenna.ai | QAS | Class II | |
| K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | QJZ | Class II | |
| K240803 | Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC | DZE | Class II | |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | BIOTRONIK AG | DQY | Class II | |
| K240168 | N7-S | Nuga Medical Co Ltd | JFB | Class II | |
| K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | OOK | Class II | |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Spectrum Medical Inc | DTZ | Class II | |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co.,Ltd | PDJ | Class II | |
| DEN230081 | Hearing Aid Feature (HAF) | Apple Inc. | SCR | Class II | |
| K241954 | SonoBlock; SonoBlock II | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K241745 | Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) | KSG Medicare Sdn Bhd | LZA | Class I | |
| K241438 | Signus Tetris™ St; Signus Tetris™ R St | Signus Medizintechnik GmbH | MAX | Class II | |
| K241380 | Fetoly-Heart | Diagnoly | IYN | Class II | |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics, Inc. | QEW | Class II | |
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | Leltek Inc. | IYN | Class II | |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | DePuy Mitek, Inc. | MAI | Class II | |
| K241004 | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | Huizhou LVB Maternal and Infant Supplies Co., Ltd. | HGX | Class II | |
| K240683 | Rx Knee System | Signature Orthopaedics Pty Limited | JWH | Class II | |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | BZQ | Class II | |
| K232559 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd. | EBF | Class II | |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc | DTK | Class II | |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | Intuitive Surgical, Inc. | NAY | Class II | |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | KWS | Class II |