HIR · Class II · 21 CFR 884.1425

FDA Product Code HIR: Perineometer

Leading manufacturers include Pelvital USA, Inc., Renovia, Inc. and X6 Innovations.

65
Total
65
Cleared
212d
Avg days
1979
Since
Declining activity - 2 submissions in the last 2 years vs 5 in the prior period
Consistent review times: 185d avg (recent)

FDA 510(k) Cleared Perineometer Devices (Product Code HIR)

65 devices
1–24 of 65
Cleared Apr 27, 2026
Pelvic Floor Exerciser (PF01)
K252748
Hunan Accurate Bio-Medical Technology Co., Ltd.
Gastroenterology & Urology · 241d
Cleared Aug 01, 2024
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
K240805
Pelvital USA, Inc.
Gastroenterology & Urology · 129d
Cleared Feb 22, 2024
Vaginal Tactile Ultrasound Imager
K231875
Advanced Tactile Imaging, Inc.
Obstetrics & Gynecology · 241d
Cleared Dec 29, 2023
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
K233362
Pelvital USA, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 20, 2023
Perifit Care+
K231780
X6 Innovations
Gastroenterology & Urology · 187d
Cleared Feb 10, 2023
Perifit
K221476
X6 Innovations
Gastroenterology & Urology · 266d
Cleared Jun 30, 2022
leva Pelvic Health System
K213913
Renovia, Inc.
Gastroenterology & Urology · 197d
Cleared Sep 21, 2021
Flyte
K212655
Pelvital USA, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 08, 2021
Leva Pelvic Health System
K212495
Renovia, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 13, 2021
Flyte
K210764
Pelvital USA, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 24, 2020
Intimate Rose Kegel Exercise System
K193364
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 264d
Cleared Jul 10, 2020
Pelvital System
K200409
Pelvital USA, Inc.
Gastroenterology & Urology · 142d
Cleared Nov 22, 2019
LEva Pelvic Digital Health System
K192270
Renovia, Inc.
Obstetrics & Gynecology · 92d
Cleared Apr 04, 2018
leva Pelvic Floor Trainer
K180637
Renovia, Inc.
Gastroenterology & Urology · 23d

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 510(k) Review Time - HIR Product Code

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 →