Cleared Traditional

Oral/Enteral Syringe (K210621) - FDA 510(k) Clearance

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

K210621 · Ningbo Tianyi Medical Appliance Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2021
Decision
57d
Days
Class 2
Risk

K210621 is an FDA 510(k) clearance for the Oral/Enteral Syringe. 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 April 28, 2021 after a review of 57 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 K210621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2021
Decision Date April 28, 2021
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
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 K210621.
ENFit Reusable Enteral Syringe
K203613 · Shantou Wealy Medical Instrument Co.,Ltd · Aug 2021
Oral/Enteral Syringe with ENFit connector
K211025 · Ningbo Tianyi Medical Appliance Co., Ltd. · Jun 2021
ENFit Disposable Enteral Syringe
K203410 · Shantou Wealy Medical Instrument Co.,Ltd · Jun 2021
Medline ENfit OTC Feeding Syringe
K202285 · Medline Industries, Inc. · Oct 2020
Enteral Feeding Syringes with ENfit connector (Model: 10 ml
K200557 · Jiangsu Shenli Medical Production Co., Ltd. · Sep 2020
Disposable Enteral Feeding Syringe with Enfit Connector
K193657 · Shinva Ande Healthcare Apparatus Co., Ltd. · Sep 2020