Cleared Traditional

K820778 - RESPIRATION MONITOR 1000

K820778 is an FDA 510(k) clearance for RESPIRATION MONITOR 1000, manufactured by Intl. Medical Devices , Ltd.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K820778 · Intl. Medical Devices , Ltd. · Anesthesiology device
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May 1982
Decision
41d
Days
Class 2
Risk

K820778 is an FDA 510(k) clearance for the RESPIRATION MONITOR 1000. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Intl. Medical Devices , Ltd. (Walker, US). The FDA issued a Cleared decision on May 3, 1982 after a review of 41 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.

View all Intl. Medical Devices , Ltd. devices

FDA 510(k) Submission Details - K820778

510(k) Number K820778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date May 03, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
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 112
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K820778.
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983
TRIMED 510 APNEA MONITOR
K822819 · Tri-Med, Inc. · Nov 1982
HEALTHDYNE MODEL 16900 INFANT MONITOR
K821731 · Healthdyne, Inc. · Jul 1982
INFANT MONITOR
K820645 · Healthdyne, Inc. · Apr 1982
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · Honeywell, Inc. · Oct 1981
VMA PEDIATRIC APNEA MATTRESS
K811865 · Vickers America Medical Corp. · Jul 1981