Nanma Vacuum Pump

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K993909 ↗

FDA Product Code

LKY

Device Class

Class II

Regulation

21 CFR Part 876.5020

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Nanma Ajustable Constriction Ring

  Class II

  FDA 510(k) K993908 Active Cleared 31 Jan 2000

• Modification to Nanma Vacuum Pump

  Class II

  FDA 510(k) K013113 Active Cleared 20 Dec 2002

• Nanma Vacuum Pump

  Class II

  FDA 510(k) K030913 Active Cleared 3 Jun 2003

• Nanma Adjustable Constriction Ring

  Class II

  FDA 510(k) K030119 Active Cleared 6 Aug 2003

• Nanma Non-Adjustable Constriction Ring

  Class II

  FDA 510(k) K993906 Active Cleared 31 Jan 2000

• Nanma Vacuum Pump Proxzek Model 2M9498S

  Class II

  FDA 510(k) K041573 Active Cleared 25 Aug 2004

See all devices from Nanma Mfg Co., Ltd. →

• What is the primary use of the Nanma Vacuum Pump in clinical settings?

  The Nanma Vacuum Pump is designed to generate controlled vacuum pressure for external penile rigidity applications. This aids in diagnostic or therapeutic procedures related to assessing or treating erectile function, such as evaluating penile function or assisting in erectile dysfunction therapy.

• Is the Nanma Vacuum Pump intended for single-use or reusable applications?

  The Nanma Vacuum Pump can be used either as a single-use device or as a reusable device, depending on the specific model and manufacturer’s instructions. This flexibility allows for different clinical workflows based on facility preferences and infection control protocols.

• How should the Nanma Vacuum Pump be stored to ensure proper functionality?

  Storage and handling of the Nanma Vacuum Pump must comply with FDA guidelines for medical devices. While the device can be supplied in either sterile or non-sterile form, it is critical to follow manufacturer instructions for storage conditions to maintain its performance and safety, particularly if reused.

• What regulatory pathway was followed for FDA clearance of the Nanma Vacuum Pump?

  The Nanma Vacuum Pump received FDA clearance through a 510(k) submission (K030913, Product Code LKY) under the Traditional clearance type. It was reviewed by the Gastroenterology and Urology (GU) Advisory Committee and classified as Substantially Equivalent (SESE) to a predicate device, confirming its compliance with FDA regulations for external penile rigidity devices.