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 |
|---|---|---|---|---|---|
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | FAJ | Class II | |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries Inc | MNR | Class II | |
| K242216 | Gentafix® (1, 3, 3Mv) | Teknimed SAS | MBB | Class II | |
| K241395 | Active System; Avenue8 | Caerus Corporation | ILX | Class II | |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark ApS | MQL | Class II | |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark ApS | MQL | Class II | |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc | FPA | Class II | |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical Ltd | LIT | Class II | |
| K240959 | Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. | BYI | Class II | |
| K240765 | Porous Biologic Scaffold | Ventris Medical | MQV | Class II | |
| K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | EWL | Class II | |
| K243664 | Sentinel Camera | Ai Optics | HKI | Class II | |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Healgen Scientific LLC | NGL | Class II | |
| K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona Inc | EBI | Class II | |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited | GEX | Class II | |
| K242869 | prodisc® L Instruments | Centinel Spine, LLC | QLQ | Class II | |
| K242816 | Quantium | Bisco Inc | EBF | Class II | |
| K242815 | Pocket TENS (Ep-300) | Hivox Biotek Inc. | NUH | Class II | |
| K242783 | Roche Digital Pathology Dx | Ventana Medical Systems Inc | PSY | Class II | |
| K242558 | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. | LZA | Class I | |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Vizionfocus Inc. | LPL | Class II | |
| K242297 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | |
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Smith & Nephew Medical Ltd | KGN | Unclassified | |
| K241801 | Tornus ES | Asahi Intecc Co., Ltd. | FGE | Class II | |
| K241616 | ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. | NHA | Class II | |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Boblingen GmbH | DPS | Class II | |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | JOJ | Class II | |
| K240798 | Cntrl+ Bladder Support Pessary | Cntrl+, Inc. | HHW | Class II | |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | MID | Class II | |
| K243641 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | |
| K243471 | Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | LQR | Class II | |
| K243066 | Dental Implants and Abutments | Ditron Dental Ltd | DZE | Class II | |
| K242307 | ACHIEVE Partial Knee System | Ignite Orthomotion | NJD | Class II | |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | IZL | Class II | |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap Inc | JXG | Class II | |
| K240937 | Aim (N/a) | Inventeur, LLC | CCK | Class II | |
| K240873 | TEMBO Embolic System | Instylla, Inc. | KRD | Class II | |
| K240809 | LUOFUCON® Silver Collagen Dressing | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K240793 | MSKai | Mskai | QIH | Class II | |
| K240676 | ULTIMUS Series Ultrasound Diagnostic System | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | |
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. | LPL | Class II | |
| K242124 | Sim&Size | Sim&cure | PZO | Class II | |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | |
| K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | OLO | Class II | |
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | Abbott Medical | DYB | Class II | |
| K243307 | LCD Monitor (MDEC-2523) | Barco N.V. | GCJ | Class II | |
| K243281 | LOCK-IN Spinal Fixation System | Lock-In USA Corp | NKB | Class II | |
| K243196 | Uro-G HD Cystoscope (1520) | Uroviu Corporation | FAJ | Class II | |
| K242668 | Gastro Concepts Air Assist | Gastro Concepts | FER | Class II | |
| K242532 | Btl-785Bnf-E | BTL Industries, Inc | NFO | Class II |