Cleared Special

K151702 - Reusable Full Silicone Cover

K151702 is an FDA 510(k) clearance for Reusable Full Silicone Cover, manufactured by Laerdal Medical AS. The device is a Class 2 Cardiovascular device with product code LIX cleared through the Special 510(k) pathway after a 50-day FDA review.

K151702 · Laerdal Medical AS · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
50d
Days
Class 2
Risk

K151702 is an FDA 510(k) clearance for the Reusable Full Silicone Cover. Classified as Aid, Cardiopulmonary Resuscitation (product code LIX), Class II - Special Controls.

Submitted by Laerdal Medical AS (Stavanger, NO). The FDA issued a Cleared decision on August 13, 2015 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Laerdal Medical AS devices

FDA 510(k) Submission Details - K151702

510(k) Number K151702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2015
Decision Date August 13, 2015
Days to Decision 50 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

LIX Device Classification - Class 2, Special Controls

Product Code LIX Aid, Cardiopulmonary Resuscitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5210
Definition Cpr Aid Device With Feedback (visual, Audio Or Both) On One Or More Cpr Parameters (e.g., Rate, Depth, Ventilation Ratio, Etc.), And Contains Software. Provides Real-time Feedback On Cpr Performance. Feedback Can Be Audio, Visual Or Both. Device Contains Software
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

MED Institute
DAN DILLON

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 - LIX Aid, Cardiopulmonary Resuscitation

All 12
Devices cleared under the same product code (LIX) and FDA review panel - the closest regulatory comparables to K151702.
CPR BAND
K201581 · Credo · Mar 2021
Reusable Silicone Cover CPRmeter 2
K183348 · Laerdal Medical AS · Dec 2018
CPRmeter 2 CPR Feedback Device
K173886 · Laerdal Medical AS · Mar 2018
CPR RSQ ASSIST
K123248 · Avantech, Inc. · Dec 2013
TRUECPR COACHING DEVICE
K123597 · Physio-Control, Inc. · Apr 2013
CPRMETER CPR FEEDBACK DEVICE
K122050 · Laerdal Medical A/S · Oct 2012