Cleared Traditional

K802205 - ECG/RESPIRATION STIMULATOR

K802205 is an FDA 510(k) clearance for ECG/RESPIRATION STIMULATOR, 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 22-day FDA review.

K802205 · Healthdyne, Inc. · Anesthesiology device
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Oct 1980
Decision
22d
Days
Class 2
Risk

K802205 is an FDA 510(k) clearance for the ECG/RESPIRATION STIMULATOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Walker, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 22 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 - K802205

510(k) Number K802205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1980
Decision Date October 03, 1980
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 K802205.
RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)
K811265 · Impact Instrumentation, Inc. · Jun 1981
NEO NATAL RESPIRATION FUNCTION BLOCK
K810175 · Honeywell, Inc. · Mar 1981
RESPIRATION FUNCTION BLOCKS
K810174 · Honeywell, Inc. · Mar 1981
PDS MODEL 3000 ADULT RESPIRATION MODULE
K802046 · General Electric Co. · Sep 1980
GOWN, SURGICAL, SURGINE
K770250 · Surgikos, Inc. · Mar 1977
MONITOR, RESPIRATORY (CPAP)
K760339 · Sherwood Medical Industries · Oct 1976