# K092746: Micronjet 600

- Pathway: 510(k) (Traditional)
- Applicant: Nanopass Technologies, Ltd.
- Decided: Feb 3, 2010 after 148 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: 2 generations back to K941657 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980796: Terumo Allergy Syringe, Terumo Corp. (1998) Summary page 2.
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set, Bd (2002) Summary page 2.
- K992734: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1999) Summary page 2.

## Indications for use
The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for intradermal injections of any substance or drug approved for this delivery route.

Source page: https://510kreport.com/device/K092746
Methodology: https://510kreport.com/methodology