Cleared Abbreviated

K141384 - WHISPERJECT AUTOINJECTOR (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K141384 · Scandinavian Health Limited · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2014
Decision
108d
Days
Class 2
Risk

K141384 is an FDA 510(k) clearance for the WHISPERJECT AUTOINJECTOR. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Scandinavian Health Limited (Deerfield Beach, US). The FDA issued a Cleared decision on September 12, 2014 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Scandinavian Health Limited devices

Submission Details

510(k) Number K141384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date September 12, 2014
Days to Decision 108 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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.