Cleared Traditional

K102174 - ZOLL PROPAQ M

K102174 is an FDA 510(k) clearance for ZOLL PROPAQ M, manufactured by Zoll Medical Corporation, World Wide Headquarters. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K102174 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular device
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Sep 2010
Decision
44d
Days
Class 2
Risk

K102174 is an FDA 510(k) clearance for the ZOLL PROPAQ M. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Zoll Medical Corporation, World Wide Headquarters (Chelsmford, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Zoll Medical Corporation, World Wide Headquarters devices

FDA 510(k) Submission Details - K102174

510(k) Number K102174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date September 15, 2010
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Peers - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 193
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