Cleared Traditional

K221700 - AutoPulse NXT Resuscitation System

K221700 is an FDA 510(k) clearance for AutoPulse NXT Resuscitation System, manufactured by Zoll Circulation, Inc.. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K221700 · Zoll Circulation, Inc. · Cardiovascular device
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Mar 2023
Decision
269d
Days
Class 2
Risk

K221700 is an FDA 510(k) clearance for the AutoPulse NXT Resuscitation System. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Zoll Circulation, Inc. (San Jose, US). The FDA issued a Cleared decision on March 9, 2023 after a review of 269 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - 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: 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 Zoll Circulation, Inc. devices

FDA 510(k) Submission Details - K221700

510(k) Number K221700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2022
Decision Date March 09, 2023
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRM Device Classification - Class 2, Special Controls

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.