Cleared Traditional

SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS (K923988) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923988 · Sensor Medics Corp. · Anesthesiology device
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Oct 1993
Decision
437d
Days
Class 2
Risk

K923988 is an FDA 510(k) clearance for the SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Yorba Linda, US). The FDA issued a Cleared decision on October 21, 1993 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Sensor Medics Corp. devices

Submission Details

510(k) Number K923988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date October 21, 1993
Days to Decision 437 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
297d slower than avg
Panel avg: 140d · This submission: 437d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 29
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