Cleared Traditional

K222155 - Single Use O-ring gasket syringe with E...

K222155 is the FDA 510(k) clearance for Single Use O-ring gasket syringe with E... by Jiangsu Caina Medical Co.,Ltd. It is a Class 2 Gastroenterology & Urology device (product code PNR) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K222155 · Jiangsu Caina Medical Co.,Ltd · Gastroenterology & Urology device
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Sep 2022
Decision
58d
Days
Class 2
Risk

K222155 is an FDA 510(k) clearance for the Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket.... Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on September 16, 2022 after a review of 58 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 Jiangsu Caina Medical Co.,Ltd devices

Submission Details

510(k) Number K222155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2022
Decision Date September 16, 2022
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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 23
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K222155.
Monoject™ Enteral Syringe with ENFit Connector (401SE)
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K222772 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023
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