# K042907: Needle Incapacitator (Needle Guard)

- Pathway: 510(k) (Traditional)
- Applicant: Pdmp, Inc.
- Decided: Dec 22, 2004 after 62 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luer-lock syringe. The Needle Guard will accept any standard disposable syringe body or luer-lock needle. Standard syringe and needle luer-lock are defined as any syringe without a mechanical safety device attached. Needle Guard will accept any gauge needle and needles up to and including a length of one and one-half inches (1 1/2"). It is a one-handed procedure that is used immediately after the use of the syringe at point of procedure. The NEEDLE GUARD can be disposed of individually or once the tray is full, of encapsulated needles and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard. The device is for use by health care professionals in hospitals and private practices, research laboratories, specialized medicines applications, clinics, nursing homes, home care and a multitude of other applications, i.e., onsite emergency care, needle exchange programs, dental offices, veterinarians, mortuaries. Caution: U.S.A. law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K042907
Methodology: https://510kreport.com/methodology