Cleared Traditional

K812792 - PFT SCREENER (SYSTEM 1100)

K812792 is an FDA 510(k) clearance for PFT SCREENER (SYSTEM 1100), manufactured by Medical Graphics Corp.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K812792 · Medical Graphics Corp. · Anesthesiology device
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Nov 1981
Decision
52d
Days
Class 2
Risk

K812792 is an FDA 510(k) clearance for the PFT SCREENER (SYSTEM 1100). Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Medical Graphics Corp. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 - K812792

510(k) Number K812792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date November 27, 1981
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 140d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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.