Cleared Traditional

K161979 - ENFit enteral syringe

K161979 is an FDA 510(k) clearance for ENFit enteral syringe, manufactured by Jiangyin Caina Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PNR cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K161979 · Jiangyin Caina Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Mar 2017
Decision
247d
Days
Class 2
Risk

K161979 is an FDA 510(k) clearance for the ENFit enteral syringe. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Jiangyin Caina Technology Co., Ltd. (Jiangyin, CN). The FDA issued a Cleared decision on March 22, 2017 after a review of 247 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.

View all Jiangyin Caina Technology Co., Ltd. devices

FDA 510(k) Submission Details - K161979

510(k) Number K161979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date March 22, 2017
Days to Decision 247 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 131d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNR Device Classification - Class 2, Special Controls

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 Consultant

Mid-Link Consulting Co, Ltd.
DIANA HONG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PNR Enteral Syringes With Enteral Specific Connectors

All 34
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K161979.
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
K170371 · Intervene Group Limited · Oct 2017
Tamper Evident Cap For use with ENFit Syringes
K170672 · International Medical Industries, Inc. · Oct 2017
ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
K161141 · Pentaferte Italia S.R.L. · Mar 2017
Medela Low Dose Enteral Syringe
K161811 · Medela, Inc. · Feb 2017
U&U Enteral Syringe
K160855 · U&U Medical Technology Co, Ltd. · Nov 2016
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
K162188 · Vr Medical Technology · Sep 2016