Cleared Traditional

K791503 - VITALOGRAPH FUNCTION ANALYZER

K791503 is an FDA 510(k) clearance for VITALOGRAPH FUNCTION ANALYZER, manufactured by Vitalograph , Ltd.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K791503 · Vitalograph , Ltd. · Anesthesiology device
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Aug 1979
Decision
8d
Days
Class 2
Risk

K791503 is an FDA 510(k) clearance for the VITALOGRAPH FUNCTION ANALYZER. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Vitalograph , Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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: 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 Vitalograph , Ltd. devices

FDA 510(k) Submission Details - K791503

510(k) Number K791503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1979
Decision Date August 16, 1979
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
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 28
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K791503.
SPIROMETRIC COMPUTER #SC-10
K802928 · Cavitron Corp. · Dec 1980
INFANT VENTILATORY MEASUREMENT SYSTEM
K801497 · Medical Graphics Corp. · Oct 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