Cleared Traditional

K914424 - MODEL 6213 REMOTE ALARM

K914424 is the FDA 510(k) clearance for MODEL 6213 REMOTE ALARM by Aequitron Medical, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K914424 · Aequitron Medical, Inc. · Anesthesiology device
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Sep 1992
Decision
343d
Days
Class 2
Risk

K914424 is an FDA 510(k) clearance for the MODEL 6213 REMOTE ALARM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 10, 1992 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aequitron Medical, Inc. devices

Submission Details

510(k) Number K914424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1991
Decision Date September 10, 1992
Days to Decision 343 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 140d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 120
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K914424.
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · Merit Medical Systems, Inc. · Jan 1993
MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50
K920002 · Puritan Bennett Corp. · Nov 1992
PURITAN-BENNETT MODEL 7200AE VENTILATOR
K923809 · Puritan Bennett Corp. · Oct 1992
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
K915312 · Puritan Bennett Corp. · Jul 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991