Cleared Traditional

K853848 - RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K853848 · Medical Graphics Corp. · Anesthesiology device
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Dec 1985
Decision
80d
Days
Class 1
Risk

K853848 is an FDA 510(k) clearance for the RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR. Classified as Calibrator, Volume, Gas (product code BXW), Class I - General Controls.

Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1870 - 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

Submission Details

510(k) Number K853848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date December 05, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 139d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXW Calibrator, Volume, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1870
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.