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Bull's-Eye Disposable Needle Recapping Aid

by Hunter Research Laboratories, Inc.

510(k) K002213

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002213 Date3 Oct 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bull's-Eye Disposable Needle Recapping Aid is a device designed to assist in the recapping of hypodermic needles. It is classified under the product code FMI and regulation 880.5570 as a needle, hypodermic, single lumen.

This device received FDA 510(k) clearance K002213 on October 3, 2000, as substantially equivalent to a legally marketed predicate. It is intended for use in general hospital settings and is supplied as a disposable aid for needle recapping procedures.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Bull’s-Eye Disposable Needle Recapping Aid specifically designed to do in a clinical setting?

    This device is designed to assist healthcare professionals in safely recapping hypodermic needles, reducing the risk of accidental needle sticks during the process. It is intended for use in general hospital environments where recapping needles is part of standard procedure.

  • Is the Bull’s-Eye Disposable Needle Recapping Aid meant for reuse, or is it single-use only?

    The device is explicitly labeled as disposable, meaning it is intended for single-use only. After use, it should be discarded to prevent contamination or reuse-related risks.

  • How is the Bull’s-Eye Disposable Needle Recapping Aid supplied, and what should I expect in the packaging?

    The device is supplied as a disposable aid, though the exact packaging details (e.g., quantity per box, sterilization method) are not specified in the provided data. It is intended for one-time use per unit, so each unit is likely pre-packaged for individual procedures.

  • What type of needles is this recapping aid compatible with, and does it come in different sizes or models?

    The device is designed for single-lumen hypodermic needles, but the specific needle gauge or size compatibility is not detailed in the provided data. It is classified under product code FMI, which generally covers hypodermic needles, but no variations in sizes or models are mentioned.