Cleared Traditional

K170371 - DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170371 · Intervene Group Limited · Gastroenterology & Urology device
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Oct 2017
Decision
256d
Days
Class 2
Risk

K170371 is an FDA 510(k) clearance for the DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syrin.... Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Intervene Group Limited (Uxbridge, GB). The FDA issued a Cleared decision on October 20, 2017 after a review of 256 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K170371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2017
Decision Date October 20, 2017
Days to Decision 256 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 130d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNR Enteral Syringes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PNR Enteral Syringes With Enteral Specific Connectors

All 33
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K170371.
Profoject Enteral/Oral Feeding Syringe
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Profoject™ Enteral Feeding Syringe
K251585 · CMT Health PTE., Ltd. · Jul 2025
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · Cardinalhealth · Dec 2024
Nutricair Enteral Syringe with ENFit
K231300 · Cair Lgl · Oct 2023
Oral/Enteral Syringe with ENFit connector
K222772 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
K222155 · Jiangsu Caina Medical Co.,Ltd · Sep 2022