Cleared Traditional

RHYTHM OF LIFE, MODEL R0901-05 (K092408) - FDA 510(k) Clearance

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

K092408 · Rapid Response Solutions, LLC · Cardiovascular device
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Oct 2009
Decision
69d
Days
Class 2
Risk

K092408 is an FDA 510(k) clearance for the RHYTHM OF LIFE, MODEL R0901-05. Classified as Aid, Cardiopulmonary Resuscitation (product code LIX), Class II - Special Controls.

Submitted by Rapid Response Solutions, LLC (Hialeah, US). The FDA issued a Cleared decision on October 14, 2009 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rapid Response Solutions, LLC devices

Submission Details

510(k) Number K092408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2009
Decision Date October 14, 2009
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.