Cleared Abbreviated

K141384 - WHISPERJECT AUTOINJECTOR

K141384 is an FDA 510(k) clearance for WHISPERJECT AUTOINJECTOR, manufactured by Scandinavian Health Limited. The device is a Class 2 General Hospital device with product code KZH cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K141384 · Scandinavian Health Limited · General Hospital
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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

FDA 510(k) Submission Details - K141384

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
Combination Product No
PCCP Authorized No
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.

KZH Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KZH Introducer, Syringe Needle

All 33
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K141384.
AccuSert Needle Inserter
K213429 · Emed Technologies Corporation · Oct 2022
Orbit Inserter
K163400 · Ypsomed AG · Jul 2017
MiniMed Quick-serter
K160860 · Medtronic Minimed · Sep 2016
LOBSTER AUTO-INJECTOR
K124026 · Scandinavian Health Limited · Sep 2013
AUTOJECT 2 FOR GLASSY SYRINGE
K122837 · Owen Mumford, Ltd. · Oct 2012
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · Elcam Medical Acal · Feb 2012

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.