Cleared Traditional

SYSTEM VI MONITOR (K874326) - FDA 510(k) Clearance

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

K874326 · Air-Shields, Inc. · Cardiovascular device
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Dec 1988
Decision
411d
Days
Class 2
Risk

K874326 is an FDA 510(k) clearance for the SYSTEM VI MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Air-Shields, Inc. devices

Submission Details

510(k) Number K874326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1987
Decision Date December 05, 1988
Days to Decision 411 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
286d slower than avg
Panel avg: 125d · This submission: 411d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 121
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K874326.
NKA MODELS AB-601G AND AB-621G
K900272 · Nihon Kohden America, Inc. · Jan 1990
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · Quinton, Inc. · Jan 1989
Q5000 ST/HR SLOPE MODIFICATION
K883468 · Quinton, Inc. · Dec 1988
OEC-7102 ECG/NIBP MONITOR
K882254 · Nihon Kohden America, Inc. · Nov 1988
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987
Q5000 STRESS TEST MONITOR
K864504 · Quinton, Inc. · Apr 1987