RectalPro 75 Endorectal Balloon
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- RectalPro75 EUDAMEDQLRAD FDA UDI
- Generic Name
- Prostate immobilization balloon catheter FDA UDI
- Device Name
- RectalPro75 Switch Valve EUDAMEDRectalPro75, switch valve LL with 100 cc Syringe FDA UDI
- Model / Reference
- 105.1018 EUDAMEDFDA UDI
- Description
- RectalPro75, switch valve LL with 100 cc Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719326258263 EUDAMEDFDA UDI
- Basic UDI-DI
- 87193262582105.1018RU EUDAMED
- 510(k) Number
- FDA Product Code
- PCT FDA 510(k)FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Prostate immobilization balloon catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5720 FDA 510(k)
- Regulation Number
- 892.5720 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The RectalPro 75 Endorectal Balloon is a Prostate Immobilizer Rectal Balloon, classified as a Class II medical device. It is designed to immobilize the prostate during radiation therapy by inflating within the rectum, ensuring precise and stable positioning for targeted treatment.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K180478) and the EU Medical Device Regulation (MDR). The balloon is available in a standardized size (75 mm) and must be stored in a clean, dry environment prior to use. Compliance with MRI safety standards is not applicable, as it is not intended for use in MRI environments.
Frequently asked questions
What is the primary purpose of the RectalPro 75 Endorectal Balloon during radiation therapy?
The RectalPro 75 Endorectal Balloon is designed to immobilize the prostate by inflating within the rectum, ensuring stable and precise positioning during radiation therapy. This helps maintain consistent treatment accuracy by reducing movement of the prostate, which is critical for effective targeting.
Is the RectalPro 75 Endorectal Balloon reusable, or is it meant for single-use only?
The device is explicitly intended for single-use only, as stated in its specifications. This ensures sterility and safety for each patient, reducing the risk of contamination or cross-infection between procedures.
What storage conditions are required for the RectalPro 75 Endorectal Balloon before use?
The device must be stored in a clean, dry environment prior to use. This helps maintain its integrity and sterility, ensuring it remains ready for single-use applications without exposure to moisture or contaminants.
Are there different sizes available for the RectalPro 75 Endorectal Balloon, or is it only offered in one standardized length?
The RectalPro 75 Endorectal Balloon is supplied in a single standardized size of 75 mm, making it a uniform solution for prostate immobilization during radiation therapy.
Can the RectalPro 75 Endorectal Balloon be used in an MRI environment, or is it MRI-safe?
The device is not intended for use in MRI environments, and compliance with MRI safety standards is explicitly noted as not applicable. This means it should not be used in facilities where MRI procedures are performed.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180478 | Class II | Active |
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Manufacturer
- Manufacturer
- QLRAD international Ltd
- FDA Applicant
- Qlrad International , Ltd.
Sources (3)
- FDA 510(k) K180478 24 fields · synced Sep 18, 2026
- FDA UDI cf099d9b-1568-4618-afaa-84f5c02922e4 35 fields · synced May 29, 2026
- EUDAMED 6d418a0e-6368-4718-91fe-b9cc20db5c70 61 fields · synced Jul 23, 2026