Safe Cap Needle Recapping/Uncapping Device

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

510(k) Number

K952518 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Disposable Disc Filter

  Class II

  FDA 510(k) K936015 Active Cleared 12 Dec 1994

• Chemo-Spike II Reconstitution Device

  Class II

  FDA 510(k) K974431 Active Cleared 8 Jan 1998

• 2 Micron Air Eliminating Filter

  Class II

  FDA 510(k) K942532 Active Cleared 17 Aug 1994

• What is the SAFE CAP Needle Recapping/Uncapping Device used for?

  The SAFE CAP Needle Recapping/Uncapping Device is designed to prevent needlestick injuries by enabling safe handling of needles after use. It allows healthcare workers to recap or uncap needles without direct hand contact, reducing the risk of accidental sticks during needle handling procedures in clinical environments where needles are used and require safe recapping or uncapping.

• Is the SAFE CAP Needle Recapping/Uncapping Device reusable or single-use?

  The SAFE CAP Needle Recapping/Uncapping Device is supplied as a reusable system. It is designed for multiple uses and can be sterilized between applications, making it suitable for repeated use in healthcare settings where infection control protocols require sterilization of reusable equipment.

• How is the SAFE CAP Needle Recapping/Uncapping Device sterilized between uses?

  The SAFE CAP Needle Recapping/Uncapping Device is autoclavable for sterilization between uses. This means it can withstand the high temperature and pressure of an autoclave cycle, which is a standard method for sterilizing reusable medical devices in healthcare facilities to ensure they are free of microorganisms before each use.

• What regulatory clearance does the SAFE CAP Needle Recapping/Uncapping Device have?

  The SAFE CAP Needle Recapping/Uncapping Device received FDA 510(k) clearance under submission number K952518 on July 28, 1995. It was determined to be substantially equivalent to a predicate device and is classified under product code FMI, which pertains to general hospital devices.

• Does the SAFE CAP Needle Recapping/Uncapping Device come in different sizes or models?

  The provided device data does not specify any particular sizes, models, or variations for the SAFE CAP Needle Recapping/Uncapping Device. No size options, model numbers, or dimensional details are included in the authorization or specifications section, indicating that the device is offered as a single standard configuration.