Cleared Traditional

K853047 - MONAGHAN RVM, MODEL 760 OR MODEL 761

K853047 is an FDA 510(k) clearance for MONAGHAN RVM, manufactured by Monaghan Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K853047 · Monaghan Medical Corp. · Anesthesiology device
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Nov 1985
Decision
122d
Days
Class 2
Risk

K853047 is an FDA 510(k) clearance for the MONAGHAN RVM, MODEL 760 OR MODEL 761. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on November 18, 1985 after a review of 122 days - within the typical 510(k) review window.

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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K853047

510(k) Number K853047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date November 18, 1985
Days to Decision 122 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
18d faster than avg
Panel avg: 140d · This submission: 122d
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 87
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K853047.
AS165 RESPIRATION MONITOR
K861743 · Air-Shields, Inc. · May 1986
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
K860455 · Oxford Medilog, Inc. · Apr 1986
HEALTHDYNE'S EVENT RECORDER SYSTEM
K860254 · Healthdyne, Inc. · Jan 1986
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
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · Edentec Corp. · Jul 1985