Cleared Special

HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 (K062119) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062119 · Medical Products Mfg., LLC · Cardiovascular device
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Sep 2006
Decision
59d
Days
Class 2
Risk

K062119 is an FDA 510(k) clearance for the HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Medical Products Mfg., LLC (North Attleboro, US). The FDA issued a Cleared decision on September 22, 2006 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - 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 Medical Products Mfg., LLC devices

Submission Details

510(k) Number K062119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2006
Decision Date September 22, 2006
Days to Decision 59 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRM Compressor, Cardiac, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5200
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.