Cleared Traditional

K912189 - LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 ...

K912189 · Physio-Control Corp. · Cardiovascular device
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Feb 1992
Decision
273d
Days
-
Risk

K912189 is an FDA 510(k) clearance for the LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 273 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Physio-Control Corp. devices

FDA 510(k) Submission Details - K912189

510(k) Number K912189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1991
Decision Date February 14, 1992
Days to Decision 273 days
Submission Type Traditional
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
148d slower than avg
Panel avg: 125d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 46
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