Cleared Traditional

K912946 - COLLINS DIGITAL PULMONARY MANOMETER

K912946 is an FDA 510(k) clearance for COLLINS DIGITAL PULMONARY MANOMETER, manufactured by Warren E. Collins, Inc.. The device is a Class 2 Anesthesiology device with product code BXR cleared through the Traditional 510(k) pathway after a 194-day FDA review.

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

FDA 510(k) Submission Details - K912946

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
54d slower than avg
Panel avg: 140d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXR Device Classification - Class 2, Special Controls

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.