# K082908: Novaguard, Model 3611001

- Pathway: 510(k) (Abbreviated)
- Applicant: West Pharmaceutical Services, Inc.
- Decided: Apr 24, 2009 after 206 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
Longest line of descent: 4 generations back to K904198 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043397: Modification to BD Eclipse Hypodermic Needle, Becton, Dickinson & CO (2004) Summary page 1.
- K951254: Safetyglide Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.
- K012736: Monoject Safety Needle, Tyco Healthcare (2001) Summary page 1.
- K040531: Terumo SURGUARD2 Safety Needle, Terumo Medical Corp. (2004) Summary page 1.

## Indications for use
The primary function of the NOVAguard MT Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.

Source page: https://510kreport.com/device/K082908
Methodology: https://510kreport.com/methodology