510(k) · Cleared

Cleared

DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories

K170900510(k) TraditionalCleared Nov 9, 2017227-day reviewClass II21 CFR 880.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intervene Group, Ltd. · FMF Syringe, Piston

Cleared on Nov 9, 2017 as substantially equivalent to K151766 (Becton, Dickinson and Company, 2015) and 7 other predicates after a 227-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.

Decided: Nov 9, 2017
Review: 227 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 8

Its longest line of descent runs back 3 generations to K965017 (1997). 19 ancestors in all, the oldest K801343 (1980). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK965017 Regional Anesthesia TraysSmiths Industries Medical Systems, Inc. · 1997 · Recalled
2 generations backK092657 Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc. · 2009
1 generation backK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
This deviceK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
Descendant · cites it directly · 0 of its ownK201031 NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K965017	Regional Anesthesia Trays	Smiths Industries Medical Systems, Inc.	1997	7
−2	K092657	Epifuse Catheter Connector, Model: 4909E	Smiths Medical Asd, Inc.	2009	—
−1	K110053	Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor…	Smiths Medical Asd, Inc.	2012	—
0 (this device)	K170900	DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…	Intervene Group, Ltd.	2017	—
+1	K201031	NRFit® Caps, Male and Female Neuraxial Tip Caps	International Medical Industries, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1982	1	0
1992	1	0
1993	1	0
1994	1	0
1996	1	0
1998	2	0
2000	2	0
2001	1	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2015	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K170900, 1997–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMF device

#1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (10)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K151766	BD Single Use, Hypodermic Syringe Summary page 7 …ringe Manufacturer and Becton, Dickenson PAJUNK GmbH Smiths Medical Clearance Number and Company Medizintechnologie K151766 K110053 K160297 {Modification…	Becton, Dickinson and Company	2015	—
*	K081524	Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic… Summary page 7 …iths Medical Clearance Number device, Inc. Medizintechnologie K110053 K081524 K160297 {Modification of PAJUNK Tuohy…	Spectra Medical Devices, Inc.	2008	—
*	K110053	Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit Summary page 7 …PAJUNK GmbH Smiths Medical Clearance Number and Company Medizintechnologie K151766 K110053 K160297 {Modification of PAJUNK Tuohy…	Smiths Medical Asd, Inc.	2012	—
*	K083451	Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays Summary page 8 …al, Inc. and Clearance Company K083451 K093920 K112515 Number…	Smiths Medical Asd, Inc.	2009	—
*	K093920	Busse Epidural Catheter Kit Summary page 8 …Company K083451 K093920 K112515 Number K161075, K143581…	Busse Hospital Disposables	2010	—
*	K112515	Pencan Spinal Needle Summary page 8 …Company K083451 K093920 K112515 Number K161075, K143581…	B.Braun Medical, Inc.	2011	—
*	K954953	B-D Durasafe Combined Spinal Epidural (Cse) Tray Summary page 8 …K112515 Number K161075, K143581 K954953 Product Code BSN CAZ BSO BSP…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	—
*	K974006	Becton Dickinson Twinpak Summary page 9 …110053 Inc. K110053 Number 2) Becton Dickinson. K974006 Product Code CAZ 1) CAZ 2) FMI Classification…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	—
*	—	B.Braun Filter Straw Named without a submission number			—
*	—	Tuohy Borst adapter supplied in the EpiLong set for Anesthesiology, supplied by Pajunk Named without a submission number			—
†	K160297	Tuohy NRFit	PAJUNK GmbH Medizintechnologie	2016	—
†	K161075	Arrow Epidural Catheter Kit	Teleflexmedical, Inc.	2016	—
†	K143581	Arrow Epidural Catheter Kit	Teleflexmedical, Inc.	2015	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K201031	NRFit® Caps, Male and Female Neuraxial Tip Caps	International Medical Industries, Inc.	2020	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
5 of the 19 ancestors have a recall of any class.
Of its descendants, K201031 (International Medical Industries, Inc., 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	23	90	6	674
2008	9	74	11	691
2009	14	94	15	913
2010	11	130	12	679
2011	16	109	3	186
2012	9	86	6	307
2013	12	154	1	326
2014	13	84	1	244
2015	11	87	2	273
2016	12	146	0	684
2017	13	135	3	1,858
2018	8	87	2	3,952
2019	11	146	1	5,863
2020	15	107	2	5,334
2021	20	175	1	5,874
2022	24	211	2	5,233
2023	22	173	19 (18)	5,214
2024	14	130	0	5,122
2025	13	114	0	4,181
2026	9	239	2 (1)	—

What is it indicated for?

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…

Read the full statement (313 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K170900 · printed Nov 5, 2026

Cite this page

510(k) Report. “K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170900

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026