FDA product code HIR: Perineometer
HIR is the FDA product code for perineometer. It is a Class II device, regulated under 21 CFR 884.1425 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 65 510(k) submissions under HIR, 7 in the last five years, from 41 different applicants. The average 510(k) review took 212 days (median 166); 213 days on average over the last three years. FDA has posted 1 recall for HIR devices.
Classification
| Field | Value |
|---|---|
| Device name | Perineometer |
| Device class | Class II |
| Regulation | 21 CFR 884.1425 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for HIR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 159 |
| 2018 | 1 | 23 |
| 2019 | 1 | 92 |
| 2020 | 2 | 203 |
| 2021 | 3 | 29 |
| 2022 | 1 | 197 |
| 2023 | 3 | 180 |
| 2024 | 2 | 185 |
| 2026 | 1 | 241 |
Compare with all 510(k) review times · Search every HIR clearance
Top HIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pelvital USA, Inc. | 5 | 2024-08-01 |
| Renovia, Inc. | 4 | 2022-06-30 |
| Hollister, Inc. | 4 | 2002-03-19 |
| Verimed Holdings, Inc. | 3 | 1998-11-20 |
| Thought Technology , Ltd. | 3 | 1995-09-29 |
36 more applicants have HIR clearances. See the full list in Caduvo.
Most recent HIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252748 | Hunan Accurate Bio-Medical Technology Co., Ltd. | Pelvic Floor Exerciser (PF01) | 2026-04-27 | 241 |
| K240805 | Pelvital USA, Inc. | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | 2024-08-01 | 129 |
| K231875 | Advanced Tactile Imaging, Inc. | Vaginal Tactile Ultrasound Imager | 2024-02-22 | 241 |
| K233362 | Pelvital USA, Inc. | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | 2023-12-29 | 88 |
| K231780 | X6 Innovations | Perifit Care+ | 2023-12-20 | 187 |
Recalls for HIR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-07-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code HIR?
HIR is the FDA product code for perineometer. It is a Class II device, regulated under 21 CFR 884.1425 and reviewed by the Gastroenterology and Urology panel.
What device class is HIR?
Class II, regulation 21 CFR 884.1425. Typical premarket route: 510(k).
How long does a 510(k) take for product code HIR?
Across 65 cleared submissions the average was 212 days from receipt to decision (median 166).
Which companies have the most HIR clearances?
Pelvital USA, Inc. (5); Renovia, Inc. (4); Hollister, Inc. (4); Verimed Holdings, Inc. (3); Thought Technology , Ltd. (3).
Have HIR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-07-12.
Next steps
- Run an FDA pathway report with predicate devices for product code HIR
- Run a recall and safety report across every HIR manufacturer
- Watch product code HIR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times