FDA Product Code HIR: Perineometer
Leading manufacturers include Advanced Tactile Imaging, Inc., Pelvital USA, Inc. and Hunan Accurate Bio-Medical Technology Co., Ltd..
FDA 510(k) Cleared Perineometer Devices (Product Code HIR)
About Product Code HIR - Regulatory Context
510(k) Submission Activity
65 total 510(k) submissions under product code HIR since 1979, with 65 receiving FDA clearance (average review time: 212 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
FDA review times for HIR submissions have been consistent, averaging 185 days recently vs 212 days historically.
HIR devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →