Product code HIR— Obstetrics/Gynecology
Flyte
- Classification name
- Perineometer
- Device class
- Class 2
- Regulation
- 21 CFR 884.1425
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 65
- First cleared
- Most recent
Market context for product code HIR
FDA has cleared devices under product code HIR between 1979 and 2026, filed by 41 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2009
- 2002
Top applicants under product code HIR
Recent clearances under product code HIR
- K252748 — Pelvic Floor Exerciser (PF01)
- K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
- K231875 — Vaginal Tactile Ultrasound Imager
- K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
- K231780 — Perifit Care+
- K221476 — Perifit
- K213913 — leva Pelvic Health System
- K212655 — Flyte
- K212495 — Leva Pelvic Health System
- K210764 — Flyte
- K193364 — Intimate Rose Kegel Exercise System
- K200409 — Pelvital System
- K192270 — LEva Pelvic Digital Health System
- K180637 — leva Pelvic Floor Trainer
- K171896 — Feminine Personal Trainer (FPT)
- K162689 — Vibrance Pelvic Trainer
- K160758 — PeriCoach OTC
- K142355 — Vaginal Tactile Imager
- K143580 — PeriCoach
- K141893 — VIBRANCE KEGEL DEVICE (VKD)
- K133990 — IEVA REHABILITATIVE POSITIONAL DEVICE
- K140780 — KEGEL SMART, KEGELSMART PEARL
- K122800 — INNER PEACE
- K121902 — NATRATONE
- K082436 — EXTT-101
- K023305 — KEGELMASTER 2000
- K021115 — GYNEFLEX
- K011688 — PELVICFLEXER EXERCISE DEVICE
- K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM
- K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
- K002043 — PELVEX HOMETRAINER
- K002617 — PERIFORM PERINEOMETRIC PROBE, MODEL 8300
- K002830 — PELVIC MUSCLE THERAPY
- K002834 — SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
- K994079 — REFLEX TREATMENT SYSTEM
- K993411 — FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
- K981277 — PERIFORM
- K983052 — PERITRON PERINEOMETER MODEL 9300V OR 9300A
- K974036 — PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
- K970145 — PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
- K960508 — PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
- K960311 — PERINEOMETER
- K945611 — PERITRON
- K952688 — INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
- K925681 — MYOTRAC2D/CS
- K934552 — PERIPUMP
- K945937 — TE-800 PELVIC FLOOR EXERCISER
- K942563 — ELITE BIOFEEDBACK
- K932149 — THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
- K935213 — INCONTROL
- K940091 — INNOVA VAGINAL EMG SENSING ELECTRODE
- K926218 — EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)
- K913912 — VERIMED PERINEOMETER
- K911190 — PERRYMETER(TM)
- K892888 — EXTACISER PERINEAL MUSCLE EXERCISER
- K891774 — CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
- K861858 — VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363
- K862410 — MILEX KEGEL PERINEAL EXERCISER
- K854193 — ELECTRO-MYOGRAPHIC PERINEOMETER
- K861683 — MONSANTO SANTOPRENE (PERITONE DEVICE)
- K860552 — PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
- K821664 — PP-100, PERSONAL PERINEOMETER
- K800191 — PERITONE
- K800303 — ELECTRONIC PERINEOMETER
- K782083 — VAGATEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.