# K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intervene Group, Ltd.
- Decided: Nov 9, 2017 after 227 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: 3 generations back to K965017 (1997). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151766: BD Single Use, Hypodermic Syringe, Becton, Dickinson and Company (2015) Summary page 7.
- K081524: Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic Loss of Resistance Syringe L/L, Spectra Medical Devices, Inc. (2008) Summary page 7.
- K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit, Smiths Medical Asd, Inc. (2012) Summary page 7.
- K083451: Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays, Smiths Medical Asd, Inc. (2009) Summary page 8.
- K093920: Busse Epidural Catheter Kit, Busse Hospital Disposables (2010) Summary page 8.
- K112515: Pencan Spinal Needle, B.Braun Medical, Inc. (2011) Summary page 8.
- K954953: B-D Durasafe Combined Spinal Epidural (Cse) Tray, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 8.
- K974006: Becton Dickinson Twinpak, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 9.
- (no number) B.Braun Filter Straw: named in the summary without a submission number
- (no number) Tuohy Borst adapter supplied in the EpiLong set for Anesthesiology, supplied by Pajunk: named in the summary without a submission number

## Most influential descendants
- K201031: NRFit® Caps, Male and Female Neuraxial Tip Caps (2020), 0 descendants of its own

## Indications for use
The DASH 6® NRFit Lock syringe and DASH® NRFit Slip Syringe are intended to be used with ISO 80369-6 NRFit neuraxial compliant devices for administration of neuraxial medication. The DASH 6® NRFit Plastic LOR Device is intended to be used with [SO 80369-6 NRFit neuraxial compliant epidural needle for locating the epidural space. Accessories: DASH 6® Introducer Needle is intended to be used with ISO 80369-6 NRFit neuraxial compliant spinal needle for guiding the placement of the spinal needle into the arachnoid/epidural space. DASH 6® NRFit Syringe Cap is intended to be used with ISO 80369-6 NRFit neuraxial syringes for sealing the tip of the syringe. DASH 6® NRFit Drawing Up Filter Straw are intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic. DASH 6® NRFit Blunt Drawing Up Needle (with and without filter) is intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic. DASH 6® NRFit Bacterial Disc Filter is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic. DASH 6® NRFit Epidural Flat Filter is intended to be used with [SO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic. DASH 6® NRFit Tuohy-Borst Adapter is intended to be used with a epidural catheter to provide an ISO 80369-6 NRFit compliant connection. DASH 6® NRFit Syringe to Syringe Adapter is intended to be used with ISO 80369-6 NRFit neuraxial syringe to allow for mixing/transfering medication between two syringes. DASH 6® NRFit Needle Hub Cap is intended for sealing the hub of an NRFit compliant needle. DASH 6® NRFit Epidural Catheter Feeder is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to assist the insertion of an epidural needle into the epidural space.

Source page: https://510kreport.com/device/K170900
Methodology: https://510kreport.com/methodology