FDA product code OVB: Hydrogel Spacer
OVB is the FDA product code for hydrogel spacer. It is a Class II device, regulated under 21 CFR 892.5725 and reviewed by the Radiology panel. FDA has cleared 6 510(k) submissions under OVB, 3 in the last five years, from 4 different applicants. The average 510(k) review took 125 days (median 55); 27 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for OVB devices, 2 initiated in the last five years.
Definition
The perirectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patients body over time.
Classification
| Field | Value |
|---|---|
| Device name | Hydrogel Spacer |
| Device class | Class II |
| Regulation | 21 CFR 892.5725 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for OVB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 21 |
| 2019 | 1 | 266 |
| 2020 | 1 | 21 |
| 2022 | 1 | 83 |
| 2023 | 1 | 332 |
| 2026 | 1 | 27 |
Top OVB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corporation | 2 | 2026-02-10 |
| Augmenix, Inc. | 2 | 2019-07-19 |
| Bioprotect, Ltd. | 1 | 2023-08-25 |
| Palette Life Sciences | 1 | 2022-05-26 |
Most recent OVB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260119 | Boston Scientific Corporation | SpaceOAR Vue System (SV-2101) | 2026-02-10 | 27 |
| K222972 | Bioprotect, Ltd. | BioProtect Balloon Implant System | 2023-08-25 | 332 |
| K220641 | Palette Life Sciences | Barrigel Injectable Gel | 2022-05-26 | 83 |
| K202224 | Boston Scientific Corporation | SpaceOAR System | 2020-08-28 | 21 |
| K182971 | Augmenix, Inc. | SpaceOAR Vue Hydrogel | 2019-07-19 | 266 |
Recalls for OVB devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-02-24.
| Year | Recalls |
|---|---|
| 2022 | 2 |
Frequently asked questions
What is FDA product code OVB?
OVB is the FDA product code for hydrogel spacer. It is a Class II device, regulated under 21 CFR 892.5725 and reviewed by the Radiology panel.
What device class is OVB?
Class II, regulation 21 CFR 892.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVB?
Across 6 cleared submissions the average was 125 days from receipt to decision (median 55).
Which companies have the most OVB clearances?
Boston Scientific Corporation (2); Augmenix, Inc. (2); Bioprotect, Ltd. (1); Palette Life Sciences (1).
Have OVB devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2022-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code OVB
- Run a recall and safety report across every OVB manufacturer
- Watch product code OVB 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.