Cleared Traditional

K151777 - Intradermal Adapter

K151777 is an FDA 510(k) clearance for Intradermal Adapter, manufactured by West Pharmaceutical Services, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K151777 · West Pharmaceutical Services, Inc. · General Hospital
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Sep 2015
Decision
90d
Days
Class 2
Risk

K151777 is an FDA 510(k) clearance for the Intradermal Adapter. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by West Pharmaceutical Services, Inc. (Exton, US). The FDA issued a Cleared decision on September 29, 2015 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all West Pharmaceutical Services, Inc. devices

FDA 510(k) Submission Details - K151777

510(k) Number K151777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date September 29, 2015
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 334
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K151777.
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · Jul 2016
LITe BIO Delivery System
K160978 · Stryker Corporation · Jul 2016
Merit 20 mL Syringe
K152783 · Merit Medical Systems, Inc. · Dec 2015
BD Single Use, Hypodermic Syringe
K151766 · Becton, Dickinson and Company · Sep 2015
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014