Cleared Traditional

K820645 - INFANT MONITOR

K820645 is an FDA 510(k) clearance for INFANT MONITOR, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K820645 · Healthdyne, Inc. · Anesthesiology device
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Apr 1982
Decision
37d
Days
Class 2
Risk

K820645 is an FDA 510(k) clearance for the INFANT MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 15, 1982 after a review of 37 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K820645

510(k) Number K820645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1982
Decision Date April 15, 1982
Days to Decision 37 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
103d faster than avg
Panel avg: 140d · This submission: 37d
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 K820645.
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
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · Honeywell, Inc. · Oct 1981
VMA PEDIATRIC APNEA MATTRESS
K811865 · Vickers America Medical Corp. · Jul 1981
RESPIRATORY SENSOR
K811014 · Impact Instrumentation, Inc. · Jun 1981