Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HIR — Predicate Candidate Screening
65 FDA 510(k) clearances under this product code; the 50 most recent screened below.
166 daysmedian FDA review time
387 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 | 241 | 0 |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | 2024-08-01 | 129 | 0 |
| K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | 2024-02-22 | 241 | 0 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | 2023-12-29 | 88 | 0 |
| K231780 | Perifit Care+ | X6 Innovations | 2023-12-20 | 187 | 0 |
| K221476 | Perifit | X6 Innovations | 2023-02-10 | 266 | 0 |
| K213913 | leva Pelvic Health System | Renovia, Inc. | 2022-06-30 | 197 | 0 |
| K212655 | Flyte | Pelvital USA, Inc. | 2021-09-21 | 29 | 0 |
| K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021-09-08 | 30 | 0 |
| K210764 | Flyte | Pelvital USA, Inc. | 2021-04-13 | 29 | 0 |
| K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | 2020-08-24 | 264 | 0 |
| K200409 | Pelvital System | Pelvital USA, Inc. | 2020-07-10 | 142 | 0 |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019-11-22 | 92 | 0 |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018-04-04 | 23 | 0 |
| K171896 | Feminine Personal Trainer (FPT) | Ralston Group | 2017-08-29 | 64 | 0 |
| K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | 2017-06-08 | 254 | 0 |
| K160758 | PeriCoach OTC | Analytica, Ltd. | 2016-07-11 | 115 | 0 |
| K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | 2015-05-28 | 276 | 0 |
| K143580 | PeriCoach | Analytica, Ltd. | 2015-03-18 | 90 | 0 |
| K141893 | VIBRANCE KEGEL DEVICE (VKD) | Bioinfinity (M) Sdn. Bhd. | 2014-12-18 | 157 | 0 |
| K133990 | IEVA REHABILITATIVE POSITIONAL DEVICE | Remendium Labs, LLC | 2014-10-09 | 286 | 0 |
| K140780 | KEGEL SMART, KEGELSMART PEARL | Regulatory Insight, Inc. | 2014-09-10 | 166 | 0 |
| K122800 | INNER PEACE | Kamabry, Inc., Dba Inner Peace For Women | 2013-10-04 | 387 | 0 |
| K121902 | NATRATONE | Orelle Corporation, Ltd. | 2013-06-06 | 342 | 0 |
| K082436 | EXTT-101 | Apimeds, Inc. | 2009-05-29 | 277 | 0 |
| K023305 | KEGELMASTER 2000 | Kegelmaster 2000 , Ltd. | 2002-12-26 | 84 | 0 |
| K021115 | GYNEFLEX | Naissance Holdings, LC | 2002-12-20 | 256 | 0 |
| K011688 | PELVICFLEXER EXERCISE DEVICE | Pelvicflex, Inc. | 2002-03-20 | 293 | 0 |
| K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM | Hollister, Inc. | 2002-03-19 | 134 | 0 |
| K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL | Hollister, Inc. | 2002-03-05 | 119 | 0 |
| K002043 | PELVEX HOMETRAINER | Purdue Technology Park | 2001-05-21 | 320 | 0 |
| K002617 | PERIFORM PERINEOMETRIC PROBE, MODEL 8300 | Neen Design , Ltd. | 2001-04-05 | 225 | 0 |
| K002830 | PELVIC MUSCLE THERAPY | Colonial Medical Supply | 2000-12-27 | 107 | 0 |
| K002834 | SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG | Srs Medical Systems, Inc. | 2000-11-29 | 78 | 0 |
| K994079 | REFLEX TREATMENT SYSTEM | Deschutes Medical Products, Inc. | 2000-03-01 | 90 | 0 |
| K993411 | FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL | Mega Electronics , Ltd. | 2000-01-10 | 90 | 0 |
| K981277 | PERIFORM | Verimed Holdings, Inc. | 1998-11-20 | 226 | 0 |
| K983052 | PERITRON PERINEOMETER MODEL 9300V OR 9300A | Cardio Design Pty. , Ltd. | 1998-10-19 | 48 | 0 |
| K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | The Prometheus Group | 1997-12-22 | 59 | 0 |
| K970145 | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VA | Biosearch Medical Products, Inc. | 1997-08-11 | 208 | 0 |
| K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/M | The Prometheus Group | 1997-01-16 | 346 | 0 |
| K960311 | PERINEOMETER | Hollister, Inc. | 1996-04-18 | 87 | 0 |
| K945611 | PERITRON | Cardio Design Pty. , Ltd. | 1996-02-08 | 450 | 0 |
| K952688 | INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE | Empi | 1995-12-06 | 177 | 0 |
| K925681 | MYOTRAC2D/CS | Thought Technology , Ltd. | 1995-09-29 | 1081 | 0 |
| K934552 | PERIPUMP | Deschutes Medical Products, Inc. | 1995-08-09 | 687 | 0 |
| K945937 | TE-800 PELVIC FLOOR EXERCISER | Myo/Kinetic Systems, Inc. | 1995-07-14 | 221 | 0 |
| K942563 | ELITE BIOFEEDBACK | Laborie Medical Technologies, Ltd. | 1995-06-06 | 371 | 0 |
| K935213 | INCONTROL | Thought Technology , Ltd. | 1995-05-11 | 559 | 0 |
| K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE | Thought Technology , Ltd. | 1995-05-11 | 737 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda