FDA product code PCT: Prostate Immobilizer Rectal Balloon
PCT is the FDA product code for prostate immobilizer rectal balloon. It is a Class II device, regulated under 21 CFR 892.5720 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under PCT, 1 in the last five years, from 4 different applicants. The average 510(k) review took 149 days (median 137). 1 De Novo request was granted under it. FDA has posted 2 recalls for PCT devices, 2 initiated in the last five years.
Definition
Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.
Classification
| Field | Value |
|---|---|
| Device name | Prostate Immobilizer Rectal Balloon |
| Device class | Class II |
| Regulation | 21 CFR 892.5720 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PCT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 264 |
| 2023 | 1 | 151 |
Compare with all 510(k) review times · Search every PCT clearance
Top PCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dxtx Medical, Inc. | 1 | 2023-02-10 |
| Qlrad International , Ltd. | 1 | 2018-11-13 |
| Myriad Medical, LLC | 1 | 2015-03-31 |
| Edge Medical, LLC | 1 | 2014-11-18 |
Most recent PCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223249 | Dxtx Medical, Inc. | Pro-Tx Endorectal Balloon (PROT-25) | 2023-02-10 | 151 |
| K180478 | Qlrad International , Ltd. | RectalPro 75 Endorectal Balloon | 2018-11-13 | 264 |
| K150234 | Myriad Medical, LLC | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | 2015-03-31 | 57 |
| K141958 | Edge Medical, LLC | ERB ENDORECTAL BALLOON | 2014-11-18 | 123 |
Recalls for PCT devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-02-04.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code PCT?
PCT is the FDA product code for prostate immobilizer rectal balloon. It is a Class II device, regulated under 21 CFR 892.5720 and reviewed by the Radiology panel.
What device class is PCT?
Class II, regulation 21 CFR 892.5720. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCT?
Across 4 cleared submissions the average was 149 days from receipt to decision (median 137).
Which companies have the most PCT clearances?
Dxtx Medical, Inc. (1); Qlrad International , Ltd. (1); Myriad Medical, LLC (1); Edge Medical, LLC (1).
Have PCT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-02-04.
Next steps
- Run an FDA pathway report with predicate devices for product code PCT
- Run a recall and safety report across every PCT manufacturer
- Watch product code PCT 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.
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