Cleared Traditional

K844327 - EDENTEC MODEL 2000W APNEA MONITOR

K844327 is an FDA 510(k) clearance for EDENTEC MODEL 2000W APNEA MONITOR, manufactured by Edentec Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K844327 · Edentec Corp. · Anesthesiology device
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Jul 1985
Decision
250d
Days
Class 2
Risk

K844327 is an FDA 510(k) clearance for the EDENTEC MODEL 2000W APNEA MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 250 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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. Standard predicate reliance. 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 Edentec Corp. devices

FDA 510(k) Submission Details - K844327

510(k) Number K844327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1984
Decision Date July 15, 1985
Days to Decision 250 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 140d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 86
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K844327.
MONAGHAN RVM, MODEL 760 OR MODEL 761
K853047 · Monaghan Medical Corp. · Nov 1985
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K851889 · Clinical Data, Inc. · Oct 1985
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · Aequitron Medical, Inc. · Aug 1985
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
RESPIRATION & HEART RATE MONITOR 530
K843681 · Tri-Med, Inc. · Dec 1984
INFANT MONITOR 16900
K843546 · Healthdyne, Inc. · Oct 1984