Cleared Traditional

ORAL/ENTERAL SYRINGES (K100099) - FDA 510(k) Clearance

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

K100099 · Philips Children'S Medical Ventures · Gastroenterology & Urology device
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Jun 2010
Decision
152d
Days
Class 2
Risk

K100099 is an FDA 510(k) clearance for the ORAL/ENTERAL SYRINGES. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Philips Children'S Medical Ventures (Monroeville, US). The FDA issued a Cleared decision on June 14, 2010 after a review of 152 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 Philips Children'S Medical Ventures devices

Submission Details

510(k) Number K100099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2010
Decision Date June 14, 2010
Days to Decision 152 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 130d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FPD Tube, Feeding
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - FPD Tube, Feeding

All 58
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K100099.
Nutrifit
K243361 · Vygon USA · Dec 2024
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
K180236 · Vr Medical Technology Co., Ltd. · Jan 2019
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009
JEJENOSTOMY FEEDING TUBE
K971906 · Boston Scientific Corp · Aug 1997
STERILE FEEDING TUBE
K954218 · Baxter Healthcare Corp · Nov 1995
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · Abbott Laboratories · Sep 1991