Cleared Traditional

K181426 - Oral/Enteral Syringe (10 mL to 60 mL) a...

K181426 is an FDA 510(k) clearance for Oral/Enteral Syringe (10 mL to 60 mL) a..., manufactured by Jiangsu Micsafe Medical 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 133-day FDA review.

K181426 · Jiangsu Micsafe Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
133d
Days
Class 2
Risk

K181426 is an FDA 510(k) clearance for the Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (.... Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Jiangsu Micsafe Medical Technology Co., Ltd. (Yancheng, CN). The FDA issued a Cleared decision on October 11, 2018 after a review of 133 days - within the typical 510(k) review window.

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 Jiangsu Micsafe Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K181426

510(k) Number K181426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2018
Decision Date October 11, 2018
Days to Decision 133 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
3d slower than avg
Panel avg: 130d · This submission: 133d
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

Wenzhou Cytech Information Service Co., Ltd.
Helen Nan

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 K181426.
ENFit Oral / Enteral Syringe
K190502 · Jiangsu Caina Medical Co.,Ltd · Aug 2019
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
K183540 · Neomed, Inc. · Apr 2019
Enteral Feeding Syringes with Enfit Connectors
K182649 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 2018
AMSure® Enteral Feeding Syringe with ENFit Tip
K171857 · Amsino International, Inc. · Mar 2018
Monoject Enteral Syringe with ENFit Connector
K161963 · Covidien · Sep 2016
Monoject
K161045 · Covidien · Jun 2016