Cleared Traditional

K231299 - Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

K231299 is an FDA 510(k) clearance for Nutricair enteral ENFit adapter: ENFit ..., manufactured by Cair Lgl. The device is a Class 2 Gastroenterology & Urology device with product code PIO cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K231299 · Cair Lgl · Gastroenterology & Urology device
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Jan 2024
Decision
263d
Days
Class 2
Risk

K231299 is an FDA 510(k) clearance for the Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector. Classified as Enteral Specific Transition Connectors (product code PIO), Class II - Special Controls.

Submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on January 22, 2024 after a review of 263 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 Cair Lgl devices

FDA 510(k) Submission Details - K231299

510(k) Number K231299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2023
Decision Date January 22, 2024
Days to Decision 263 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
132d slower than avg
Panel avg: 131d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PIO Device Classification - Class 2, Special Controls

Product Code PIO Enteral Specific Transition Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral 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 - PIO Enteral Specific Transition Connectors

All 8
Devices cleared under the same product code (PIO) and FDA review panel - the closest regulatory comparables to K231299.
ENFit Adaptor
K233190 · Jiangsu Caina Medical Co.,Ltd · Jan 2024
Enteral Transition Adaptor
K220165 · GBUK Group, Ltd. · Oct 2022
Cedic Enteral ENFit Transition Connectors
K162254 · Cedic S.R.L. · May 2017
Nutrisafe 2- ENFit Adaptor
K151237 · Vygon · Feb 2016
Medline ENFit Connectors
K151628 · Medline Industries, Inc. · Jul 2015
AMT Enteral Transition Adapters
K150034 · Applied Medical Technology, Inc. · Jun 2015