Cleared Traditional

K801495 - CARDIO-PULMONARY EXERCISE STRESS SYSTEM

K801495 is an FDA 510(k) clearance for CARDIO-PULMONARY EXERCISE STRESS SYSTEM, manufactured by Medical Graphics Corp.. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K801495 · Medical Graphics Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1980
Decision
25d
Days
Class 2
Risk

K801495 is an FDA 510(k) clearance for the CARDIO-PULMONARY EXERCISE STRESS SYSTEM. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Medical Graphics Corp. (Walker, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1900 - 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 Medical Graphics Corp. devices

FDA 510(k) Submission Details - K801495

510(k) Number K801495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1980
Decision Date July 21, 1980
Days to Decision 25 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZM Device Classification - Class 2, Special Controls

Product Code BZM Calculator, Pulmonary Function Interpretor (diagnostic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1900
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.