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Needle Incapacitator (Needle Guard)

by Pdmp, Inc.

510(k) K042907

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 NumberK042907 Date22 Dec 2004ClearedStatusActive

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  • Withdrawn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 Needle Incapacitator (Needle Guard) is a Needle, Hypodermic, Single Lumen device designed to safely manage sharps. It functions as a mechanical sharps management system, specifically engineered to encapsulate contaminated needles and luer-lock syringes after use.

This device is intended for one-handed operation at the point-of-use and accommodates standard disposable syringes and needles up to 1.5 inches in length. Supplied as a single-use item, it is classified under FDA regulation 880.5570 and holds a 510(k) clearance (K042907) for general hospital use. No additional sterility or MRI safety information is provided in the specifications.

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 primary purpose of the Needle Incapacitator (Needle Guard) and how does it work?

    The Needle Incapacitator (Needle Guard) is designed as a mechanical sharps management system to safely encapsulate contaminated needles and luer-lock syringes after use. It functions by securely enclosing the needle and syringe in a protective casing, reducing the risk of needle-stick injuries. The device is engineered for one-handed operation at the point-of-care and accommodates standard disposable syringes with needles up to 1.5 inches in length.

  • Is the Needle Incapacitator (Needle Guard) intended for reuse or is it meant for single-use?

    The Needle Incapacitator (Needle Guard) is explicitly supplied as a single-use item. This design ensures safety and hygiene by preventing reuse, which could compromise sterility and increase the risk of contamination or injury.

  • What types of syringes and needles does the Needle Incapacitator (Needle Guard) accommodate?

    The device is designed to accommodate standard disposable syringes and needles that are up to 1.5 inches in length. It is specifically engineered to work with luer-lock syringes, ensuring a secure fit for safe encapsulation after use.

  • How is the Needle Incapacitator (Needle Guard) regulated and what does its clearance status mean?

    The Needle Incapacitator (Needle Guard) holds a 510(k) clearance (K042907) from the FDA, classified under product code FMI (Needle, Hypodermic, Single Lumen) and intended for general hospital use. The clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meaning it meets regulatory standards for safety and effectiveness in its intended application.

  • Does the Needle Incapacitator (Needle Guard) come with any specific storage instructions?

    The provided specifications do not include explicit storage instructions for the Needle Incapacitator (Needle Guard). However, as a single-use medical device, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures to maintain its integrity until use. Always follow manufacturer guidelines if additional instructions are provided elsewhere.