Cleared Traditional

K921306 - ARGIS PULMONARY FUNCTION TESTING SYSTEM

K921306 is the FDA 510(k) clearance for ARGIS PULMONARY FUNCTION TESTING SYSTEM by Med Science. It is a Class 2 Anesthesiology device (product code BZC) cleared through the Traditional 510(k) pathway after a 464-day FDA review.

K921306 · Med Science · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
464d
Days
Class 2
Risk

K921306 is an FDA 510(k) clearance for the ARGIS PULMONARY FUNCTION TESTING SYSTEM. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Med Science (Jacksonville, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Med Science devices

Submission Details

510(k) Number K921306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1992
Decision Date June 25, 1993
Days to Decision 464 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
324d slower than avg
Panel avg: 140d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K921306.
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K881235 · Quinton, Inc. · Mar 1989
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K810751 · General Electric Co. · Apr 1981
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K802920 · C.R. Bard, Inc. · Feb 1981