Cleared Traditional

K801497 - INFANT VENTILATORY MEASUREMENT SYSTEM

K801497 is an FDA 510(k) clearance for INFANT VENTILATORY MEASUREMENT SYSTEM, manufactured by Medical Graphics Corp.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K801497 · Medical Graphics Corp. · Anesthesiology device
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Oct 1980
Decision
99d
Days
Class 2
Risk

K801497 is an FDA 510(k) clearance for the INFANT VENTILATORY MEASUREMENT SYSTEM. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Medical Graphics Corp. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Graphics Corp. devices

FDA 510(k) Submission Details - K801497

510(k) Number K801497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1980
Decision Date October 03, 1980
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 23
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K801497.
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
K810751 · General Electric Co. · Apr 1981
INSPIRON PULMONARY FUNCTION ANALYZER
K802920 · C.R. Bard, Inc. · Feb 1981
SPIROMETRIC COMPUTER #SC-10
K802928 · Cavitron Corp. · Dec 1980
ANESTHESIA GAS MACHINE
K802116 · Puritan Bennett Corp. · Oct 1980
ANALYZER, PULMONARY FUNCTION
K780322 · Hospal Medical Corp. · Mar 1978
PC-30 PULMONARY COMPUTER
K770532 · Cavitron Corp. · Apr 1977