Cleared Traditional

K901466 - MESAMIV RECORDER

K901466 is an FDA 510(k) clearance for MESAMIV RECORDER, manufactured by Madaus Medtec, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K901466 · Madaus Medtec, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
72d
Days
Class 2
Risk

K901466 is an FDA 510(k) clearance for the MESAMIV RECORDER. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Madaus Medtec, Inc. (Spring House, US). The FDA issued a Cleared decision on June 8, 1990 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K901466

510(k) Number K901466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1990
Decision Date June 08, 1990
Days to Decision 72 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
68d faster than avg
Panel avg: 140d · This submission: 72d
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 175
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K901466.
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785 · Aequitron Medical, Inc. · Jul 1990
KNIGHTWATCH SYSTEM
K896934 · Createch Corp. · Jun 1990
ARVEE APNEA MONITOR, MODEL 4800
K900730 · Arvee Medical, Inc. · Jun 1990
'APNEA-ELECTRODE'
K900826 · Medical Science Products, Inc. · Apr 1990
MESAM RECORDER
K894641 · Madaus Medtec, Inc. · Jan 1990
AR-800PA RESPIRATION MODULE
K891486 · Nihon Kohden America, Inc. · Oct 1989
K901466 · MESAMIV RECORDER
Download PDF Madaus Medtec, Inc.