# K041590: Autodetect Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Indigo Orb, Inc.
- Decided: Jun 23, 2004 after 9 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925902 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001731: Avid-Nit Loss of Resistance Syringe, Avid Medical, Inc. (2000) Summary page 1.
- K925902: B-D Loss of Resistance Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1993) Summary page 1.

## Indications for use
The AutoDetect Syringe is intended for use with an epidural needle for the verification of needle tip placement in the epidural space.

Source page: https://510kreport.com/device/K041590
Methodology: https://510kreport.com/methodology