Cleared Traditional

K912946 - COLLINS DIGITAL PULMONARY MANOMETER (FDA 510(k) Clearance)

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

K912946 · Warren E. Collins, Inc. · Anesthesiology device
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Jan 1992
Decision
194d
Days
Class 2
Risk

K912946 is an FDA 510(k) clearance for the COLLINS DIGITAL PULMONARY MANOMETER. Classified as Meter, Airway Pressure (inspiratory Force) (product code BXR), Class II - Special Controls.

Submitted by Warren E. Collins, Inc. (Braintree, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 194 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1780 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Warren E. Collins, Inc. devices

Submission Details

510(k) Number K912946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1991
Decision Date January 15, 1992
Days to Decision 194 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 139d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXR Meter, Airway Pressure (inspiratory Force)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1780
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.