Cleared Traditional

K771019 - LUNG-MECHANICS MONITOR

K771019 is an FDA 510(k) clearance for LUNG-MECHANICS MONITOR, manufactured by Research Development Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K771019 · Research Development Corp. · Anesthesiology device
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Jun 1977
Decision
8d
Days
Class 2
Risk

K771019 is an FDA 510(k) clearance for the LUNG-MECHANICS MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Research Development Corp. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1977 after a review of 8 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 - K771019

510(k) Number K771019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1977
Decision Date June 14, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 140d · This submission: 8d
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 119
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K771019.
RESPIRATION FUNCTION BLOCKS
K810174 · Honeywell, Inc. · Mar 1981
ECG/RESPIRATION STIMULATOR
K802205 · Healthdyne, Inc. · Oct 1980
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
RESPIRATORY SUPPORT SYSTEM, NEONATAL
K760340 · Sherwood Medical Industries · Aug 1976