Cleared Traditional

Intradermal Adapter (K151777) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 242
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K151777.
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
K162081 · Becton, Dickinson and Company · Dec 2016
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · 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
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014