Cleared Traditional

Oral/Enteral Syringe with ENFit connector (K211025) - FDA 510(k) Clearance

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

K211025 · Ningbo Tianyi Medical Appliance Co., Ltd. · Gastroenterology & Urology device
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Jun 2021
Decision
85d
Days
Class 2
Risk

K211025 is an FDA 510(k) clearance for the Oral/Enteral Syringe with ENFit connector. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Ningbo Tianyi Medical Appliance Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on June 30, 2021 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ningbo Tianyi Medical Appliance Co., Ltd. devices

Submission Details

510(k) Number K211025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2021
Decision Date June 30, 2021
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
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 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 23
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K211025.
ENFit enteral syringes (NUTRIFIT)
K211661 · Pentaferte Italia S.R.L. · Feb 2022
Enteral Pump Syringe
K211593 · Jiangsu Caina Medical Co.,Ltd · Sep 2021
ENFit Reusable Enteral Syringe
K203613 · Shantou Wealy Medical Instrument Co.,Ltd · Aug 2021
ENFit Disposable Enteral Syringe
K203410 · Shantou Wealy Medical Instrument Co.,Ltd · Jun 2021
Oral/Enteral Syringe
K210621 · Ningbo Tianyi Medical Appliance Co., Ltd. · Apr 2021
Medline ENfit OTC Feeding Syringe
K202285 · Medline Industries, Inc. · Oct 2020