Ultra PVD

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K912925 ↗

FDA Product Code

JAF

Device Class

Class II

Regulation

21 CFR Part 892.1540

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Spectra ECG

  Not classified

  FDA 510(k) K915658 Active Cleared 10 Jun 1992

• Model Micro St Ambulatory ECG Monitor

  Class II

  FDA 510(k) K870537 Active Cleared 23 Apr 1987

• Micro Fd 7000 Ambulatory Blood Pressure Monitor

  Class II

  FDA 510(k) K896102 Active Cleared 18 Jan 1990

• Advanced Medical Products Mini-M (TENS)

  Class II

  FDA 510(k) K852836 Active Cleared 28 Aug 1985

• Model 192 Printer

  Class I

  FDA 510(k) K870538 Active Cleared 23 Apr 1987

• Micro Fl 7400 Ambulatory Holter/Bp Monitor

  Class II

  FDA 510(k) K896103 Active Cleared 18 Jan 1990

See all devices from Advanced Medical Products, Inc. →

• What clinical setting is the Ultra PVD intended for, and how does its design support its use there?

  The Ultra PVD is designed specifically for clinical radiology settings, where it aids in diagnostic assessments by generating real-time ultrasound visualizations of internal body structures. Its ultrasonic technology aligns with radiologic imaging needs, enabling clinicians to visualize anatomy without exposing patients to ionizing radiation, which is common in other imaging modalities like X-rays or CT scans.

• Is the Ultra PVD intended for single-use or reusable applications, and what does this mean for maintenance or replacement?

  The provided data does not specify whether the Ultra PVD is single-use or reusable. If reusable, it would require proper cleaning, sterilization, and maintenance protocols to ensure patient safety and device functionality. If single-use, it would need to be disposed of after one use, which impacts inventory and waste management. Always follow manufacturer guidelines or local regulations for proper handling.

• What regulatory pathway was followed for the FDA clearance of the Ultra PVD, and what does this imply about its safety and performance standards?

  The Ultra PVD was cleared under the FDA’s Traditional 510(k) pathway (K912925), meaning it was determined to be *substantially equivalent* to a legally marketed device already on the market. This implies that its safety and performance meet the established standards for existing ultrasonic nonfetal monitors, though it does not guarantee innovation or superiority—only equivalence to prior devices. The clearance was reviewed by the Radiology (RA) Advisory Committee.

• How is the Ultra PVD supplied, and are there any specific storage requirements mentioned in the data?

  The data does not provide explicit details on how the Ultra PVD is supplied (e.g., box contents, accessories) or specific storage requirements like temperature or humidity conditions. Typically, ultrasound devices require protection from physical damage and environmental contaminants, but without manufacturer instructions, clinicians should refer to the device’s user manual or consult Advanced Medical Products, Inc. for proper handling and storage guidance.