VT-1 External Penile Rigidity Device

No FDA recalls on record, checked 22 Oct 2026.

Full name

Vt-1

510(k) Number

K012619 ↗

FDA Product Code

LKY

Device Class

Class II

Regulation

21 CFR Part 876.5020

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• V.T.S., Inc. (V.T.-3)

  Class II

  FDA 510(k) K992442 Active Cleared 5 Oct 1999

• Se-200

  Class II

  FDA 510(k) K012620 Active Cleared 9 Nov 2001

• Se-300 Vacuum Therapy System

  Class II

  FDA 510(k) K012639 Active Cleared 9 Nov 2001

• Se-100 Vacuum Erection Device

  Class II

  FDA 510(k) K012662 Active Cleared 9 Nov 2001

• What clinical settings is the VT-1 External Penile Rigidity Device intended for, and how does it differ from internal solutions for penile rigidity?

  The VT-1 is designed for clinical use in urology or gastroenterology settings, providing mechanical support for penile erection without internal insertion. Unlike internal devices (e.g., implants or injectables), it applies external pressure to maintain or enhance rigidity, making it a non-invasive option for conditions like erectile dysfunction or post-prostatectomy rehabilitation. Its reusable design and external application distinguish it from devices requiring surgical implantation or internal placement.

• Is the VT-1 sterile when received, and what cleaning/maintenance is required before use?

  The VT-1 is not sterile upon packaging and must be cleaned and maintained according to the manufacturer’s instructions before clinical use. Since it is a reusable device, proper sterilization and hygiene protocols are essential to prevent contamination and ensure patient safety. Always follow Vts, Inc.’s guidelines for cleaning and storage to maintain functionality.

• What regulatory pathway was followed for FDA clearance of the VT-1, and how does this affect its use?

  The VT-1 received FDA 510(k) clearance (K012619) under the traditional review pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. This clearance confirms compliance with 21 CFR 876.5020 for external penile rigidity devices, ensuring it meets safety and performance standards for clinical use in urology or gastroenterology. The approval does not imply any specific indication but confirms regulatory validation for its intended mechanical function.

• Are there multiple sizes or models of the VT-1, and how would a clinician determine the appropriate fit for a patient?

  The provided data does not specify distinct sizes or models of the VT-1, but its design suggests it may offer adjustable or modular components to accommodate varying penile circumferences. Clinicians should refer to Vts, Inc.’s sizing guidelines or consult the manufacturer for recommendations on proper fit, ensuring the device applies controlled pressure effectively without causing discomfort or injury. Always verify compatibility with patient anatomy before use.

• Can the VT-1 be used in patients who require MRI scans, or are there any safety concerns?

  The VT-1’s MRI safety information is not specified in the provided data, meaning its compatibility with MRI procedures is not confirmed. Patients using this device should avoid MRI scans unless explicitly cleared by the manufacturer or radiology staff. Always check with Vts, Inc. or the MRI facility for potential risks, as metal components or external devices could interfere with imaging or pose safety hazards.