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 |
|---|---|---|---|---|---|
| K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | FPB | Class II | |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | Qiagen | QOF | Class II | |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen Ltd. | CAF | Class II | |
| K232475 | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd | FPA | Class II | |
| K232410 | SmartChest | Milvue | QFM | Class II | |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. | JAQ | Class II | |
| K240403 | Access BR Monitor | Siemens Healthcare Diagnostics Inc. | MOI | Class II | |
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical Inc. | PLP | Class II | |
| K234112 | Customized Abutment | ARUM DENTISTRY Co., Ltd. | NHA | Class II | |
| K233982 | CEREGLIDE 92 Catheter System | Cerenovus, Inc. | QJP | Class II | |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System | Synthes GmbH | HRS | Class II | |
| K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | PEM | Class II | |
| K233602 | P200te (A10700) | Optos PLC. | OBO | Class II | |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | MSX | Class II | |
| K232976 | VUZE System | Vuze Medical Ltd. | LLZ | Class II | |
| K232477 | Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) | Jiangxi Aov Maternity & Baby Products Co., Ltd. | HGX | Class II | |
| K232470 | Polyisoprene Extra Large Condom | Suretex, Ltd. | MOL | Class II | |
| K232468 | SC Medica FFX | SC Medica | MRW | Unclassified | |
| K232025 | Hushd Pro Avera | Good Sleep CO Pte, Ltd. | LRK | Class II | |
| K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) | Relign Corporation, Subsidiary of Zimmer Biomet | GEI | Class II | |
| K240999 | Legend X Applicator VO | Pollogen Ltd | GEI | Class II | |
| K240964 | FLOW 90? Wand | ArthroCare Corporation | GEI | Class II | |
| K233803 | UltraClear Laser System (N/A) | Acclaro Corporation | GEX | Class II | |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho-Clinical Diagnostics, Inc. | DHA | Class II | |
| K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | LPL | Class II | |
| K222292 | F&P myAirvo 3 | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | |
| K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | DSA | Class II | |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | Lexington Medical, Inc. | GAG | Class II | |
| K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System | Dentsply Sirona Inc | NHA | Class II | |
| K233864 | ASSURE Wearable ECG | KESTRA Medical Technologies, Inc. | MWJ | Class II | |
| K233766 | Geneo X Elite | Pollogen Ltd | PAY | Class II | |
| K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne Inc. | PHL | Class II | |
| K232928 | DeepContour (V1.0) | Wisdom Technologies, Inc. | QKB | Class II | |
| K232833 | HALO AP Dx | Indica Labs LLC | PSY | Class II | |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. | MQG | Class II | |
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & Co. KG | FJL | Class II | |
| K231612 | Eve Patient Positioner System | Leo Cancer Care Ltd. | JAI | Class II | |
| K240685 | Salvo® Spine System | Spine Wave Inc | NKB | Class II | |
| K240392 | JAZZ Spinal System | Implanet | NKB | Class II | |
| K240007 | Solar Compact (G4-1) | Abbott Medical | FFX | Class II | |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | KNT | Class II | |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | HRX | Class II | |
| K232514 | MIM – Dose Analysis | MIM Software Inc | LLZ | Class II | |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | LHI | Class II | |
| K240919 | Silk Voice (SMI-04) | Sofregen Medical, Inc. | MIX | Class II | |
| K240800 | Access Intrinsic Factor Ab | Siemens Healthcare Diagnostics Inc. | LIG | Class II | |
| K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | OLO | Class II | |
| K240297 | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) | US Medical Innovations, LLC | OAB | Class II | |
| K240185 | Cypris eXact Suture Placement Device | Cypris Medical, Inc. | GEJ | Class I |